[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR890.1925]

[Page 520]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 890_PHYSICAL MEDICINE DEVICES--Table of Contents
 
             Subpart B_Physical Medicine Diagnostic Devices
 
Sec. 890.1925  Isokinetic testing and evaluation system.

    (a) Identification. An isokinetic testing and evaluation system is a 
rehabilitative exercise device intended for medical purposes, such as to 
measure, evaluate, and increase the strength of muscles and the range of 
motion of joints.
    (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. 890.9.

[48 FR 53047, Nov. 23, 1983, as amended at 63 FR 59230, Nov. 3, 1998]

Subpart C [Reserved]