[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR876.2040]

[Page 354]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 876--GASTROENTEROLOGY-UROLOGY DEVICES--Table of Contents
 
                      Subpart C--Monitoring Devices
 
Sec. 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 Sec. 876.9.

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