← Product Code [LQK](/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/LQK) · P920038

# SYSTEM 37 HOME UTERINE ACTIVITY MONITORING SYSTEM (P920038)

_Matria Healthcare, Inc. · LQK · Sep 29, 1995 · Obstetrics/Gynecology · APRL_

**Canonical URL:** https://fda.innolitics.com/submissions/OBSTETRICS%2FGYNECOLOGY/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/LQK/P920038

## Device Facts

- **Applicant:** Matria Healthcare, Inc.
- **Product Code:** [LQK](/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/LQK.md)
- **Decision Date:** Sep 29, 1995
- **Decision:** APRL
- **Regulation:** 21 CFR 884.2730
- **Device Class:** Class 2
- **Review Panel:** Obstetrics/Gynecology

## Regulatory Identification

A home uterine activity monitor (HUAM) is an electronic system for at home antepartum measurement of uterine contractions. The HUAM system comprises a tocotransducer and an at-home recorder. This device is intended for use in women with a previous preterm delivery to aid in the detection of preterm labor.

## Special Controls

*Classification.* Class II (special controls); guidance document (Class II Special Controls Guidance for Home Uterine Activity Monitors).

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**Source:** [https://fda.innolitics.com/submissions/OBSTETRICS%2FGYNECOLOGY/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/LQK/P920038](https://fda.innolitics.com/submissions/OBSTETRICS%2FGYNECOLOGY/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/LQK/P920038)

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