21 C.F.R. § 888.1250 Nonpowered dynamometer.
Title 21 - Food and Drugs
(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.
Title 21: Food and Drugs
PART 888—ORTHOPEDIC DEVICES
Subpart B—Diagnostic Devices
§ 888.1250 Nonpowered dynamometer.
