Novii+ Wireless Patch System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K231964 FDA 510(k)
- FDA Product Code
- HGM FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 884.2740 FDA 510(k)
- Regulation Number
- 884.2740 FDA 510(k)
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Novii+ Wireless Patch System is a Monitoring, Perinatal device designed for continuous, non-invasive fetal heart rate and uterine contraction monitoring during pregnancy and labor. It employs wireless, disposable sensors applied to the maternal abdomen to transmit real-time data wirelessly to a central monitoring unit, enabling clinicians to assess fetal well-being and uterine activity without the need for invasive procedures or cumbersome wired connections.
This system is intended for single-use and is supplied as a sterile, disposable patch set paired with a reusable wireless receiver unit. It is classified as a Class II medical device under FDA regulations and has received FDA 510(k) clearance and MDR authorization. The wireless receiver is MRI-safe for use in non-magnetic MRI environments, and the system is designed for obstetric and gynecological settings, adhering to regulatory standards for perinatal monitoring.
Frequently asked questions
Is the Novii+ Wireless Patch System designed for repeated use on multiple patients, or is it intended for single-patient use only?
The Novii+ Wireless Patch System is explicitly designed for single-use only, as stated in the device description. The disposable patch set is intended to be used once per patient and then discarded, ensuring sterility and hygiene standards for perinatal monitoring.
What types of environments is the wireless receiver unit safe to use in, particularly concerning MRI compatibility?
The wireless receiver unit of the Novii+ Wireless Patch System is MRI-safe for use in non-magnetic MRI environments, according to the device specifications. This means it can be used in areas where MRI scans are performed, provided the environment is not highly magnetic.
How is the Novii+ Wireless Patch System supplied, and what components are included in the sterile package?
The system is supplied as a sterile, disposable patch set paired with a reusable wireless receiver unit. The disposable components (the wireless sensors) are intended for single-use and are packaged separately for hygiene, while the receiver unit is designed for repeated use across multiple patients.
What regulatory pathways has the Novii+ Wireless Patch System undergone, and which governing bodies have authorized its use?
The Novii+ Wireless Patch System has received FDA 510(k) clearance and MDR (Medical Device Regulation) authorization, confirming its compliance with U.S. and EU regulatory standards. It is classified as a Class II medical device under FDA regulations, indicating a moderate level of risk that requires pre-market review.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K231964 | Class II | Active |
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Manufacturer
- Manufacturer
- Datex-Ohmeda Inc.
- FDA Applicant
- Datex Ohmeda
Sources (2)
- FDA 510(k) K231964 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced Jun 11, 2026