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Invu by Nuvo

Nuvo Group Usa, Inc. · Model NV-INVU-0001 · UDI-DI 07290018250044

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510(k) clearances

Adverse events

Recalls

Facilities

Description

The INVU by Nuvo™ System is a safe, non-invasive wearable monitoring system that provides continuous passive monitoring of vital pregnancy data of the pregnant person and the fetus through the INVU™ App. The information it provides is: Fetal heart rate (FHR), Maternal heart rate (MHR), and Uterine Activity (UA). The INVU by Nuvo™ System (as a part of the INVU 3200 Family/Catalogue) includes a wearable sensory band NV-BTSH-3000 (INVU Sensor Band™) that connects wirelessly to the INVU™ App installed on the pregnant person’s mobile device. The system may include additional peripheral devices, such as a blood pressure measuring device, depending on the care plan prescribed by the pregnant person’s medical supervisor. The INVU™ App installed on the pregnant person’s smartphone can log the measured blood pressure. The monitored pregnancy data is displayed on the mobile device by the INVU™ App. The recorded monitored pregnancy data can also be viewed by an assigned medical supervisor (or by a remote monitoring medical service), using the INVU Pro™ web application.

Recalls

Date	Firm	Reason
2016-08-04	AirStrip Technologies, Inc.	Belt clip may become detached causing electronic components to be exposed.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.