Code of Federal Regulations Title 21. Food and Drugs § 21.884.2730 Home uterine activity monitor

(a) Identification. A home uterine activity monitor (HUAM) is an electronic system for at home antepartum measurement of uterine contractions, data transmission by telephone to a clinical setting, and for receipt and display of the uterine contraction data at the clinic. The HUAM system comprises a tocotransducer, an at-home recorder, a modem, and a computer and monitor that receive, process, and display data. 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).