21 CFR 884.2730 — Home Uterine Activity Monitor
Obstetrics/Gynecology (OB) · Part 884 Subpart C—Obstetrical and Gynecological Monitoring Devices · § 884.2730
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).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| LQK | Home Uterine Activity Monitor | 2 | 7 | |
| MOH | Monitor, Heart Rate, Fetal, Non-Stress Test (Home Use) | 2 | 0 |
Special Controls
LQK — Home Uterine Activity Monitor
*Classification.* Class II (special controls); guidance document (Class II Special Controls Guidance for Home Uterine Activity Monitors).
eCFR
LQK — Home Uterine Activity Monitor
guidance document (Class II Special Controls Guidance for Home Uterine Activity Monitors).
Ecfr Llm
MOH — Monitor, Heart Rate, Fetal, Non-Stress Test (Home Use)
*Classification.* Class II (special controls); guidance document (Class II Special Controls Guidance for Home Uterine Activity Monitors).
eCFR
