21 CFR 876.2040
§ 876.2040 Enuresis alarm.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 876.2040, § 876.2040 Enuresis alarm, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90287
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Full text
(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.
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.