{"data":{"id":"us/21-cfr-884.2730","jurisdiction":"us","citation":"21 CFR 884.2730","heading":"Home uterine activity monitor.","body":"(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.\n(b) Classification. Class II (special controls); guidance document (Class II Special Controls Guidance for Home Uterine Activity Monitors).","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 884—OBSTETRICAL AND GYNECOLOGICAL DEVICES","Subpart C—Obstetrical and Gynecological Monitoring Devices"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"ea2bbf74ced791735bf2519e1fafb11688cfd2a81e62871cc82a048cf369f4f8","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-884.2720","next":"us/21-cfr-884.2740"},"notice":"GroundRules: Original legal text. Not legal advice."}