# Novii wireless patch system (fetal heart rate from the abdomen) Product · id `maternal:novii-wireless-patch` · Maternal & Newborn Atlas · release `c7fb95f1d15a7d13` (public) > General information from published sources, not medical advice, and not reviewed by clinicians. Check the cited source before relying on anything here. The atlas's own text and curation may be reused under Creative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0, https://creativecommons.org/licenses/by-nc/4.0/): credit the atlas, and do not use it commercially. See the atlas About page. Text quoted from a source stays under that source's own terms, given as the source's reuse\_basis. The atlas's reuse terms do not cover it. The downloads list each quotation with its source in third\_party\_quotations. Browse, life stage: Pregnancy; Childbirth Browse, care area: The baby before birth ## In plain language A wireless pod and patch of electrodes stuck to the mother's abdomen that shows the baby's heart rate, the mother's heart rate and contractions without belts. FDA cleared the first version in 2014 for women in labour at more than 36 completed weeks with a single baby, and cleared Novii+ in 2023 for use before and during labour in women with a single baby at 34 weeks and 0/7 days or later, in a clinical setting. Both are described as for healthcare professionals in a clinical setting; the FDA text does not mention use at home. ## Technical summary Two 510(k) clearances (substantial equivalence, not approval): K140862 (Monica Novii Wireless Patch System, Monica Healthcare, decision 2014-08-27, intrapartum, more than 36 completed weeks, singleton) and K231964 (Novii+ Wireless Patch System, Datex Ohmeda, decision 2023-12-08, antepartum and intrapartum, 34 weeks and 0/7 days and greater, singleton). K231964 names K140862 as its predicate. The product code differs between FDA's K140862 letter (HGM) and the openFDA record (OSP); both are shown on the decision. Clinical data summarised by FDA: 31 patients in labour (K140862) and 30 subjects at 34+0 to 36+6 weeks (K231964). ## Claims, with the population each applies to ## Context: Women in labour with a singleton pregnancy at more than 36 completed weeks, monitored by healthcare professionals in a clinical setting (US labelling of K140862) Recipient: Mixed recipients; Population: Pregnant women in labour, with singleton pregnancies at more than 36 completed weeks, wearing abdominal surface electrodes. The device shows the fetal heart rate (fetus), uterine activity and the maternal heart rate (mother).; Care setting: Clinical setting, used by healthcare professionals; Geography: United States (FDA labelling); Life stage: Labour, singleton pregnancy at more than 36 completed weeks (the FDA text says >36 completed weeks; whether 36 weeks 0 days counts is not stated); Gestational age: Not reported; Postnatal age: Not reported; Follow-up: Not applicable; this is the cleared indication for use ### FDA cleared the Monica Novii Wireless Patch System (Monica Healthcare Ltd) under 510(k) K140862 on 2014-08-27. The cleared use is as an intrapartum maternal-fetal monitor that non-invasively measures and displays fetal heart rate, uterine activity and maternal heart rate from abdominal surface electrodes, on women at more than 36 completed weeks, in labour, with singleton pregnancies, used by healthcare professionals in a clinical setting. The indication names intrapartum use in a clinical setting; it does not name antepartum use or use at home. - Category: Regulatory - Evidence stage: Evidence stage not applicable - Certainty: Certainty not assessed - Applies to: Recipient: Mixed recipients; Population: Pregnant women in labour, with singleton pregnancies at more than 36 completed weeks, wearing abdominal surface electrodes. The device shows the fetal heart rate (fetus), uterine activity and the maternal heart rate (mother).; Care setting: Clinical setting, used by healthcare professionals; Geography: United States (FDA labelling); Life stage: Labour, singleton pregnancy at more than 36 completed weeks (the FDA text says >36 completed weeks; whether 36 weeks 0 days counts is not stated); Gestational age: Not reported; Postnatal age: Not reported; Follow-up: Not applicable; this is the cleared indication for use - Limitations: Clearance means FDA found the device substantially equivalent to earlier devices; it is not an approval and not a recommendation to use the device for any one woman. The sources disagree on the product code: FDA's clearance letter gives HGM (21 CFR 884.2740, class II), while the openFDA record gives OSP (21 CFR 884.2720). Both are shown and are not reconciled here; the decision records the letter's code. The 510(k) summary describes a comparison with the predicate monitor in 31 patients in labour; this record gives no accuracy numbers. Only the clearance letter, the indications, the 510(k) summary sections cited here and the openFDA record were read. - Last checked: 2026-10-14 - Sources: 1. Supports: FDA 510(k) premarket notification K140862, Monica Novii Wireless Patch System (Monica Healthcare Ltd) (Regulator, edition Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary.) Locator: Clearance letter, page 1, reference block. Retrieved 2026-10-14T18:25:40Z. Source state: Current. Snapshot hash: 40e34b8362d7788495f85253bc16dc4429c7c8b49b2d04e7fac05f753f9bfe0a. How it applies: FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only. 2. Supports: FDA 510(k) premarket notification K140862, Monica Novii Wireless Patch System (Monica Healthcare Ltd) (Regulator, edition Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary.) Locator: Indications for Use statement, paragraph 1, sentence 1, fragment 1 of 2. Retrieved 2026-10-14T18:25:40Z. Source state: Current. Snapshot hash: 40e34b8362d7788495f85253bc16dc4429c7c8b49b2d04e7fac05f753f9bfe0a. How it applies: FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only. 3. Supports: FDA 510(k) premarket notification K140862, Monica Novii Wireless Patch System (Monica Healthcare Ltd) (Regulator, edition Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary.) Locator: Indications for Use statement, paragraph 1, sentence 1, fragment 2 of 2. Retrieved 2026-10-14T18:25:40Z. Source state: Current. Snapshot hash: 40e34b8362d7788495f85253bc16dc4429c7c8b49b2d04e7fac05f753f9bfe0a. How it applies: FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only. 4. Supports: FDA 510(k) premarket notification K140862, Monica Novii Wireless Patch System (Monica Healthcare Ltd) (Regulator, edition Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary.) Locator: Indications for Use statement, paragraph 1, sentence 4. Retrieved 2026-10-14T18:25:40Z. Source state: Current. Snapshot hash: 40e34b8362d7788495f85253bc16dc4429c7c8b49b2d04e7fac05f753f9bfe0a. How it applies: FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only. 5. Supports: FDA 510(k) premarket notification K140862, Monica Novii Wireless Patch System (Monica Healthcare Ltd) (Regulator, edition Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary.) Locator: Indications for Use statement, paragraph 3. Retrieved 2026-10-14T18:25:40Z. Source state: Current. Snapshot hash: 40e34b8362d7788495f85253bc16dc4429c7c8b49b2d04e7fac05f753f9bfe0a. How it applies: FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only. 6. Supports: FDA 510(k) premarket notification K140862, Monica Novii Wireless Patch System (Monica Healthcare Ltd) (Regulator, edition Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary.) Locator: 510(k) Summary, Clinical Testing. Retrieved 2026-10-14T18:25:40Z. Source state: Current. Snapshot hash: 40e34b8362d7788495f85253bc16dc4429c7c8b49b2d04e7fac05f753f9bfe0a. How it applies: FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only. 7. Supports: FDA 510(k) premarket notification K140862, Monica Novii Wireless Patch System (Monica Healthcare Ltd) (Regulator, edition Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary.) Locator: 510(k) Summary, Clinical Testing, paragraph 2, sentence 1 continued. Retrieved 2026-10-14T18:25:40Z. Source state: Current. Snapshot hash: 40e34b8362d7788495f85253bc16dc4429c7c8b49b2d04e7fac05f753f9bfe0a. How it applies: FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only. 8. Supports: FDA 510(k) premarket notification K140862, Monica Novii Wireless Patch System (Monica Healthcare Ltd) (Regulator, edition Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary.) Locator: results\[0\].decision\_date. Retrieved 2026-10-14T18:18:30Z. Source state: Current. Snapshot hash: f62188048a514d60e43bd34f9b941360243716d8375795b9a5d5647a007a9bfa. How it applies: openFDA 510(k) record. 9. Supports: FDA 510(k) premarket notification K140862, Monica Novii Wireless Patch System (Monica Healthcare Ltd) (Regulator, edition Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary.) Locator: results\[0\].decision\_description. Retrieved 2026-10-14T18:18:30Z. Source state: Current. Snapshot hash: f62188048a514d60e43bd34f9b941360243716d8375795b9a5d5647a007a9bfa. How it applies: openFDA 510(k) record. 10. Supports: FDA 510(k) premarket notification K140862, Monica Novii Wireless Patch System (Monica Healthcare Ltd) (Regulator, edition Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary.) Locator: results\[0\].k\_number. Retrieved 2026-10-14T18:18:30Z. Source state: Current. Snapshot hash: f62188048a514d60e43bd34f9b941360243716d8375795b9a5d5647a007a9bfa. How it applies: openFDA 510(k) record. 11. Background: FDA 510(k) premarket notification K140862, Monica Novii Wireless Patch System (Monica Healthcare Ltd) (Regulator, edition Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary.) Locator: results\[0\].product\_code. Retrieved 2026-10-14T18:18:30Z. Source state: Current. Snapshot hash: f62188048a514d60e43bd34f9b941360243716d8375795b9a5d5647a007a9bfa. How it applies: Frames the population or setting. openFDA 510(k) record. 12. Background: FDA 510(k) premarket notification K140862, Monica Novii Wireless Patch System (Monica Healthcare Ltd) (Regulator, edition Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary.) Locator: results\[0\].openfda.regulation\_number. Retrieved 2026-10-14T18:18:30Z. Source state: Current. Snapshot hash: f62188048a514d60e43bd34f9b941360243716d8375795b9a5d5647a007a9bfa. How it applies: Frames the population or setting. openFDA 510(k) record. ## Context: Women at 34 weeks 0 days or later with a singleton pregnancy, antepartum or intrapartum, monitored in a clinical setting (US labelling of K231964) Recipient: Mixed recipients; Population: Pregnant women at 34 weeks and 0/7 days and greater with singleton pregnancies, wearing abdominal surface electrodes. The device shows the fetal heart rate (fetus), uterine activity and the maternal heart rate (mother).; Care setting: Clinical setting, used by healthcare professionals; Geography: United States (FDA labelling); Life stage: Antepartum and intrapartum, from 34 weeks 0 days of gestation; Gestational age: at least 34 weeks 0 days (238 days), measured at the time of measurement; Postnatal age: Not reported; Follow-up: Not applicable; this is the cleared indication for use ### FDA cleared the Novii+ Wireless Patch System (Datex Ohmeda) under 510(k) K231964 on 2023-12-08. The cleared use is as an antepartum and intrapartum maternal/fetal monitor that non-invasively measures fetal heart rate, uterine activity and maternal heart rate from abdominal surface electrodes, on women at 34 weeks and 0/7 days and greater with singleton pregnancies, used by healthcare professionals in a clinical setting. The 510(k) summary names the Monica Novii Wireless Patch system (K140862) as its predicate device. - Category: Regulatory - Evidence stage: Evidence stage not applicable - Certainty: Certainty not assessed - Applies to: Recipient: Mixed recipients; Population: Pregnant women at 34 weeks and 0/7 days and greater with singleton pregnancies, wearing abdominal surface electrodes. The device shows the fetal heart rate (fetus), uterine activity and the maternal heart rate (mother).; Care setting: Clinical setting, used by healthcare professionals; Geography: United States (FDA labelling); Life stage: Antepartum and intrapartum, from 34 weeks 0 days of gestation; Gestational age: at least 34 weeks 0 days (238 days), measured at the time of measurement; Postnatal age: Not reported; Follow-up: Not applicable; this is the cleared indication for use - Limitations: Clearance means FDA found the device substantially equivalent to a predicate; it is not an approval. The indication names a clinical setting and healthcare professionals; it does not name use at home. The clinical study described in the summary enrolled 30 subjects between 34+0 and 36+6 weeks (see the performance claim). Only the clearance letter, the indications, the 510(k) summary sections cited here and the openFDA record were read. - Last checked: 2026-10-14 - Sources: 1. Supports: FDA 510(k) premarket notification K231964, Novii+ Wireless Patch System (Datex Ohmeda) (Regulator, edition Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary.) Locator: Clearance letter, page 1, reference block. Retrieved 2026-10-14T18:25:42Z. Source state: Current. Snapshot hash: 7fcdc868b387925e686998b6cbe6633f8b8a2c3303bf7b8cf3d4678ac9bb323a. How it applies: FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only. 2. Supports: FDA 510(k) premarket notification K231964, Novii+ Wireless Patch System (Datex Ohmeda) (Regulator, edition Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary.) Locator: 510(k) Summary, Indications for Use, fragment 1 of 2. Retrieved 2026-10-14T18:25:42Z. Source state: Current. Snapshot hash: 7fcdc868b387925e686998b6cbe6633f8b8a2c3303bf7b8cf3d4678ac9bb323a. How it applies: FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only. 3. Supports: FDA 510(k) premarket notification K231964, Novii+ Wireless Patch System (Datex Ohmeda) (Regulator, edition Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary.) Locator: 510(k) Summary, Indications for Use, fragment 2 of 2. Retrieved 2026-10-14T18:25:42Z. Source state: Current. Snapshot hash: 7fcdc868b387925e686998b6cbe6633f8b8a2c3303bf7b8cf3d4678ac9bb323a. How it applies: FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only. 4. Supports: FDA 510(k) premarket notification K231964, Novii+ Wireless Patch System (Datex Ohmeda) (Regulator, edition Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary.) Locator: 510(k) Summary, Indications for Use, last paragraph. Retrieved 2026-10-14T18:25:42Z. Source state: Current. Snapshot hash: 7fcdc868b387925e686998b6cbe6633f8b8a2c3303bf7b8cf3d4678ac9bb323a. How it applies: FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only. 5. Supports: FDA 510(k) premarket notification K231964, Novii+ Wireless Patch System (Datex Ohmeda) (Regulator, edition Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary.) Locator: 510(k) Summary, predicate device row. Retrieved 2026-10-14T18:25:42Z. Source state: Current. Snapshot hash: 7fcdc868b387925e686998b6cbe6633f8b8a2c3303bf7b8cf3d4678ac9bb323a. How it applies: FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only. 6. Supports: FDA 510(k) premarket notification K231964, Novii+ Wireless Patch System (Datex Ohmeda) (Regulator, edition Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary.) Locator: results\[0\].decision\_date. Retrieved 2026-10-14T18:18:30Z. Source state: Current. Snapshot hash: 68faf7d19b287ce3e9715c5e7eee2301b2222cd6ef4365e6f7b3757158bf7cb6. How it applies: openFDA 510(k) record. 7. Supports: FDA 510(k) premarket notification K231964, Novii+ Wireless Patch System (Datex Ohmeda) (Regulator, edition Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary.) Locator: results\[0\].decision\_description. Retrieved 2026-10-14T18:18:30Z. Source state: Current. Snapshot hash: 68faf7d19b287ce3e9715c5e7eee2301b2222cd6ef4365e6f7b3757158bf7cb6. How it applies: openFDA 510(k) record. 8. Supports: FDA 510(k) premarket notification K231964, Novii+ Wireless Patch System (Datex Ohmeda) (Regulator, edition Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary.) Locator: results\[0\].product\_code. Retrieved 2026-10-14T18:18:30Z. Source state: Current. Snapshot hash: 68faf7d19b287ce3e9715c5e7eee2301b2222cd6ef4365e6f7b3757158bf7cb6. How it applies: openFDA 510(k) record. 9. Supports: FDA 510(k) premarket notification K231964, Novii+ Wireless Patch System (Datex Ohmeda) (Regulator, edition Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary.) Locator: results\[0\].openfda.regulation\_number. Retrieved 2026-10-14T18:18:30Z. Source state: Current. Snapshot hash: 68faf7d19b287ce3e9715c5e7eee2301b2222cd6ef4365e6f7b3757158bf7cb6. How it applies: openFDA 510(k) record. 10. Supports: FDA 510(k) premarket notification K231964, Novii+ Wireless Patch System (Datex Ohmeda) (Regulator, edition Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary.) Locator: results\[0\].k\_number. Retrieved 2026-10-14T18:18:30Z. Source state: Current. Snapshot hash: 68faf7d19b287ce3e9715c5e7eee2301b2222cd6ef4365e6f7b3757158bf7cb6. How it applies: openFDA 510(k) record. ## Context: Women at 34 weeks 0 days to 36 weeks 6 days, threatened preterm labour or preterm labour and delivery (Novii+ clinical study in K231964) Recipient: Mixed recipients; Population: 30 subjects enrolled between 34 weeks + 0/7 days and 36 weeks + 6/7 days of gestation: 14 with threatened preterm labour (not in labour) and 16 with preterm labour and delivery. Compared against Doppler fetal heart rate, tocodynamometer uterine activity and pulse-oximeter maternal heart rate.; Care setting: Clinical study described in an FDA 510(k) summary; setting not described in the parts read; Geography: Not stated in the summary; Life stage: Pregnancy, 34 weeks 0 days to 36 weeks 6 days; Gestational age: 34 weeks 0 days (238 days) to 36 weeks 6 days (258 days), measured at enrolment; Postnatal age: Not reported; Follow-up: Not stated in the parts read ### The 510(k) summary for Novii+ (K231964) describes a clinical study of 30 subjects enrolled between 34 weeks + 0/7 days and 36 weeks + 6/7 days: 14 with threatened preterm labour (not in labour) and 16 with preterm labour and delivery. The mean percent agreement for fetal heart rate between Novii+ and the predicate Doppler fetal heart rate was 88.08%, with a 95% lower confidence limit of 83.45%, above the 80% threshold set to demonstrate equivalence. - Category: Description - Evidence stage: Observational - Certainty: Certainty not assessed - Applies to: Recipient: Mixed recipients; Population: 30 subjects enrolled between 34 weeks + 0/7 days and 36 weeks + 6/7 days of gestation: 14 with threatened preterm labour (not in labour) and 16 with preterm labour and delivery. Compared against Doppler fetal heart rate, tocodynamometer uterine activity and pulse-oximeter maternal heart rate.; Care setting: Clinical study described in an FDA 510(k) summary; setting not described in the parts read; Geography: Not stated in the summary; Life stage: Pregnancy, 34 weeks 0 days to 36 weeks 6 days; Gestational age: 34 weeks 0 days (238 days) to 36 weeks 6 days (258 days), measured at enrolment; Postnatal age: Not reported; Follow-up: Not stated in the parts read - Limitations: This is the manufacturer's submission summary as released by FDA, not a published trial. The summary reports similar agreement tests for maternal heart rate and uterine activity that this record does not repeat. The study covers 34+0 to 36+6 weeks only, and 30 subjects. Percent agreement is not the same as clinical outcome benefit. Only the summary pages read were used. - Last checked: 2026-10-14 - Sources: 1. Supports: FDA 510(k) premarket notification K231964, Novii+ Wireless Patch System (Datex Ohmeda) (Regulator, edition Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary.) Locator: 510(k) Summary, Summary of Clinical testing, paragraph 3, sentence 1. Retrieved 2026-10-14T18:25:42Z. Source state: Current. Snapshot hash: 7fcdc868b387925e686998b6cbe6633f8b8a2c3303bf7b8cf3d4678ac9bb323a. How it applies: FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only. 2. Supports: FDA 510(k) premarket notification K231964, Novii+ Wireless Patch System (Datex Ohmeda) (Regulator, edition Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary.) Locator: 510(k) Summary, Summary of Clinical testing, paragraph 3, sentence 1 continued. Retrieved 2026-10-14T18:25:42Z. Source state: Current. Snapshot hash: 7fcdc868b387925e686998b6cbe6633f8b8a2c3303bf7b8cf3d4678ac9bb323a. How it applies: FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only. 3. Supports: FDA 510(k) premarket notification K231964, Novii+ Wireless Patch System (Datex Ohmeda) (Regulator, edition Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary.) Locator: 510(k) Summary, Summary of Clinical testing, FHR, fragment 1 of 2. Retrieved 2026-10-14T18:25:42Z. Source state: Current. Snapshot hash: 7fcdc868b387925e686998b6cbe6633f8b8a2c3303bf7b8cf3d4678ac9bb323a. How it applies: FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only. 4. Supports: FDA 510(k) premarket notification K231964, Novii+ Wireless Patch System (Datex Ohmeda) (Regulator, edition Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary.) Locator: 510(k) Summary, Summary of Clinical testing, FHR, fragment 2 of 2. Retrieved 2026-10-14T18:25:42Z. Source state: Current. Snapshot hash: 7fcdc868b387925e686998b6cbe6633f8b8a2c3303bf7b8cf3d4678ac9bb323a. How it applies: FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only. ## Guidance, authorization and access ### Regulatory decision `maternal:regdec-fda-k140862` - Product: Novii wireless patch system (fetal heart rate from the abdomen) (`maternal:novii-wireless-patch`) - Authority: U.S. Food and Drug Administration (`core:fda`) - Decision: Clearance, 2014-08-27 - Product version: Monica Novii Wireless Patch System, as cleared under K140862 - Pathway: 510(k) - Submission: K140862 - Product code: HGM - Device class: II - Indication: An intrapartum maternal-fetal monitor that non-invasively measures and displays fetal heart rate, uterine activity and maternal heart rate from abdominal surface electrodes, indicated for women at more than 36 completed weeks, in labour, with singleton pregnancies, for use by healthcare professionals in a clinical setting. - Jurisdictions: United States; note: United States - Applies to: Recipient: Mixed recipients; Population: Pregnant women in labour, with singleton pregnancies at more than 36 completed weeks, wearing abdominal surface electrodes. The device shows the fetal heart rate (fetus), uterine activity and the maternal heart rate (mother).; Care setting: Clinical setting, used by healthcare professionals; Geography: United States (FDA labelling); Life stage: Labour, singleton pregnancy at more than 36 completed weeks (the FDA text says >36 completed weeks; whether 36 weeks 0 days counts is not stated); Gestational age: Not reported; Postnatal age: Not reported; Follow-up: Not applicable; this is the cleared indication for use - Basis: claim `maternal:claim-fda-k140862-indication` ### Regulatory decision `maternal:regdec-fda-k231964` - Product: Novii wireless patch system (fetal heart rate from the abdomen) (`maternal:novii-wireless-patch`) - Authority: U.S. Food and Drug Administration (`core:fda`) - Decision: Clearance, 2023-12-08 - Product version: Novii+ Wireless Patch System, as cleared under K231964 - Pathway: 510(k) - Submission: K231964 - Product code: HGM - Device class: II - Indication: An antepartum and intrapartum maternal/fetal monitor that non-invasively measures fetal heart rate, uterine activity and maternal heart rate from abdominal surface electrodes, indicated for women at 34 weeks and 0/7 days and greater with singleton pregnancies, for use by healthcare professionals in a clinical setting. - Jurisdictions: United States; note: United States - Applies to: Recipient: Mixed recipients; Population: Pregnant women at 34 weeks and 0/7 days and greater with singleton pregnancies, wearing abdominal surface electrodes. The device shows the fetal heart rate (fetus), uterine activity and the maternal heart rate (mother).; Care setting: Clinical setting, used by healthcare professionals; Geography: United States (FDA labelling); Life stage: Antepartum and intrapartum, from 34 weeks 0 days of gestation; Gestational age: at least 34 weeks 0 days (238 days), measured at the time of measurement; Postnatal age: Not reported; Follow-up: Not applicable; this is the cleared indication for use - Basis: claim `maternal:claim-fda-k231964-indication` ## Connected pages - Abdominal ECG-based fetal heart rate: Electronic fetal heart-rate monitoring (cardiotocography) (`maternal:electronic-fetal-monitoring`) - Filed under this front: Imaging and monitoring (`maternal:front-imaging-and-monitoring`) ## Provenance Content hash: 4f027543cb9d86a9f9f1cab866e239c3b3d104dac65bab82f39367887c400ccc Last substantive edit: 2026-10-14 Evidence last checked: 2026-10-14