[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR876.5310]

[Page 368-369]
 
                        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. 876.5310  Nonimplanted, peripheral electrical continence device.

    (a) Identification. A nonimplanted, peripheral electrical continence 
device is a device that consists of an electrode that is connected by an 
electrical cable to a battery-powered pulse source. The electrode is 
placed onto or inserted into the body at a peripheral location and used 
to stimulate the nerves associated with pelvic floor function to 
maintain urinary continence. When necessary, the electrode may be 
removed by the user.
    (b) Classification. Class II, subject to the following special 
controls:
    (1) That sale, distribution, and use of this device are restricted 
to prescription use in accordance with Sec. 801.109 of this chapter.
    (2) That the labeling must bear all information required for the 
safe and effective use of the device as outlined in

[[Page 369]]

Sec. 801.109(c) of this chapter, including a detailed summary of the 
clinical information upon which the instructions are based.

[65 FR 18237, Apr. 7, 2000]