§ 884.2730 — Home Uterine Activity Monitor

(a) 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.

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