[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: 21CFR884.1425]

[Page 430]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 884--OBSTETRICAL AND GYNECOLOGICAL DEVICES--Table of Contents
 
       Subpart B--Obstetrical and Gynecological Diagnostic Devices
 
Sec. 884.1425  Perineometer.

    (a) Identification. A perineometer is a device consisting of a 
fluid-filled sack for intravaginal use that is attached to an external 
manometer. The devices measure the strength of the perineal muscles by 
offering resistence to a patient's voluntary contractions of these 
muscles and is used to diagnose and to correct, through exercise, 
uninary incontinence or sexual dysfunction.
    (b) Classification. Class II (performance standards).