21 CFR 884.2720
§ 884.2720 External uterine contraction monitor and accessories.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 884.2720, § 884.2720 External uterine contraction monitor and accessories, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90806
- Permanent ID
ys:prov:90806@1- SHA-256
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Full text
(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).
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.