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Genesis Home Uterine Activity Monitoring System

by Matria Healthcare, Inc.

PMA P890063

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

PMA P890063↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPRL NumberP890063 Date12 Sep 1990DecidedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

PMA

Full name
Genesis Home Uterine Activity Monitoring System (Huam)
Trade Name
Genesis(R) Home Uterine Activity Monitoring System
Generic Name
Monitor, uterine contraction, external (for use in clinic)
PMA Number
FDA Product Code
HFM
Device Class
Class II
Regulation
21 CFR Part 884.2720
Advisory Committee
Obstetrics/Gynecology
FDA Decision
APRL

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Genesis Home Uterine Activity Monitoring System is an external uterine contraction monitor designed for non-invasive assessment of uterine activity during pregnancy. Classified as a Monitor, Uterine Contraction, External (for use in clinic), it records contractions to aid in obstetric management, particularly for high-risk pregnancies or labor monitoring in home settings.

This system is intended for single-use or reusable applications in obstetric care, adhering to FDA PMA authorization under PMA Number P890063. Supplied as a portable device, it operates in clinical and home environments, with regulatory compliance under Regulation Number 884.2720 and Product Code HFM. Sterility and MRI safety are not specified in the data.

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