21 CFR § 888.1250 - Nonpowered dynamometer.
§ 888.1250 Nonpowered dynamometer.
(a) 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.
(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807.