[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: 21CFR876.5320]

[Page 360-361]
 
                        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 F--Therapeutic Devices
 
Sec. 876.5320  Nonimplanted electrical continence device.

    (a) Identification. A nonimplanted electrical continence device is a 
device that consists of a pair of electrodes on a plug or a pessary that 
are connected by an electrical cable to a battery-powered pulse source. 
The plug or pessary is inserted into the rectum or into the

[[Page 361]]

vagina and used to stimulate the muscles of the pelvic floor to maintain 
urinary or fecal continence. When necessary, the plug or pessary may be 
removed by the user. This device excludes an AC-powered nonimplanted 
electrical continence device and the powered vaginal muscle stimulator 
for therapeutic use (Sec. 884.5940).
    (b) Classification. Class II (performance standards).