Regulations last checked for updates: May 03, 2025

Title 21 - Food and Drugs last revised: Apr 28, 2025
§ 884.2720 - External uterine contraction monitor and accessories.

(a) Identification. An external uterine contraction monitor (i.e., the tokodynamometer) is a device used to monitor the progress of labor. It measures the duration, frequency, and relative pressure of uterine contractions with a transducer strapped to the maternal abdomen. This generic type of device may include an external pressure transducer, support straps, and other patient and equipment supports.

(b) Classification. Class II (performance standards).

authority: 21 U.S.C. 351,360,360c,360e,360j,360
source: 45 FR 12684, Feb. 26, 1980, unless otherwise noted.
cite as: 21 CFR 884.2720