21 C.F.R. § 876.2040 Enuresis alarm.
Title 21 - Food and Drugs
(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. [48 FR 53023, Nov. 23, 1983, as amended at 63 FR 59228, Nov. 3, 1998]
Title 21: Food and Drugs
PART 876—GASTROENTEROLOGY-UROLOGY DEVICES
Subpart C—Monitoring Devices
§ 876.2040 Enuresis alarm.
