CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 890—PHYSICAL MEDICINE DEVICES > SUBPART B—Physical Medicine Diagnostic Devices (§890.1175 to §890.1925) > 890.1925—Isokinetic testing and evaluation system.

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 § 890.9.

Code of Federal Regulations

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