21 C.F.R. § 890.1925

Current through October 31, 2024
Section 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 .

21 C.F.R. §890.1925

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