LQK · Home Uterine Activity Monitor
Obstetrics/Gynecology · 21 CFR 884.2730 · Class 2
Overview
| Product Code | LQK |
|---|---|
| Device Name | Home Uterine Activity Monitor |
| Regulation | 21 CFR 884.2730 |
| Device Class | Class 2 |
| Review Panel | Obstetrics/Gynecology |
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.
Classification Rationale
Class II (special controls); guidance document (Class II Special Controls Guidance for Home Uterine Activity Monitors).
Special Controls
*Classification.* Class II (special controls); guidance document (Class II Special Controls Guidance for Home Uterine Activity Monitors).
Recent Cleared Devices (7 of 7)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K221046 | Invu by Nuvo | Nuvo- Group , Ltd. | May 6, 2022 | SESE |
| K210025 | INVU by Nuvo | Nuvo- Group , Ltd. | May 28, 2021 | SESE |
| K191401 | PregSense | Nuvo- Group , Ltd. | Mar 27, 2020 | SESE |
| K143114 | Sense4Baby System Model B+ (MSA) | Airstrip Technologies, Inc. | Mar 10, 2015 | SESE |
| K020390 | MODIFICATION TO FETAL ASSIST | Huntleigh Diagnostics , Ltd. | Apr 19, 2002 | SESE |
| P920038 | SYSTEM 37 HOME UTERINE ACTIVITY MONITORING SYSTEM | Matria Healthcare, Inc. | Sep 29, 1995 | APRL |
| P910063 | CAREFONE(TM)HOME UTERINE ACTIVITY MONITOR SYSTEM | Matria Healthcare, Inc. | Sep 29, 1995 | APRL |
Top Applicants
- Nuvo- Group , Ltd. — 3 clearances
- Matria Healthcare, Inc. — 2 clearances
- Airstrip Technologies, Inc. — 1 clearance
- Huntleigh Diagnostics , Ltd. — 1 clearance
