{"data":{"id":"us/21-cfr-876.2040","jurisdiction":"us","citation":"21 CFR 876.2040","heading":"Enuresis alarm.","body":"(a) Identification. An enuresis alarm is a device intended for use in treatment of bedwetting. Through an electrical trigger mechanism, the device sounds an alarm when a small quantity of urine is detected on a sensing pad. This generic type of device includes conditioned response enuresis alarms.\n(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 876—GASTROENTEROLOGY-UROLOGY DEVICES","Subpart C—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":"50f65239a1b404700a5a74f10d6beb9d9433eb23a3af0709c1f5252812cecdb9","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-876.1800","next":"us/21-cfr-876.2050"},"notice":"GroundRules: Original legal text. Not legal advice."}