§888.1250. Nonpowered dynamometer.
21 C.F.R. § 888.1250
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.
Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807.
Notes, amendments, and revision history
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l , 371.
Source
Source: 52 FR 33702, Sept. 4, 1987, unless otherwise noted.