CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 876—GASTROENTEROLOGY-UROLOGY DEVICES > SUBPART C—Monitoring Devices (§876.2040 to §876.2040) > 876.2040—Enuresis alarm.

876.2040—Enuresis alarm.

(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.

Code of Federal Regulations

[48 FR 53023, Nov. 23, 1983, as amended at 63 FR 59228, Nov. 3, 1998]