← Product Code [LQK](/productcode/LQK) · K253673

# M•care System (MW-20) (K253673)

_Marani Health, Inc. · LQK · Sep 3, 2026 · Obstetrics/Gynecology · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K253673

## Device Facts

- **Applicant:** Marani Health, Inc.
- **Product Code:** [LQK](/productcode/LQK.md)
- **Decision Date:** Sep 3, 2026
- **Decision:** SESE
- **Submission Type:** Traditional
- **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/device/K253673](https://fda.innolitics.com/device/K253673)

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