[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR888.1250]

[Page 456]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES--(Continued)
 
PART 888--ORTHOPEDIC DEVICES--Table of Contents
 
                      Subpart B--Diagnostic Devices
 
Sec. 888.1250  Nonpowered dynamometer.

    (a) Identification. A nonpowered dynamometer is a mechanical device 
intended for medical purposes to measure the pinch and grip muscle 
strength of a patient's hand.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807.