§890.1925. Isokinetic testing and evaluation system.
21 C.F.R. § 890.1925
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.
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.
Notes, amendments, and revision history
Amendments
[48 FR 53047, Nov. 23, 1983, as amended at 63 FR 59230, Nov. 3, 1998]
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.
Source
Source: 48 FR 53047, Nov. 23, 1983, unless otherwise noted.
Amendments
[48 FR 53047, Nov. 23, 1983, as amended at 63 FR 59230, Nov. 3, 1998]