Title 21: Food and Drugs
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/ PART 888 - ORTHOPEDIC DEVICES
/ Subpart B - Diagnostic Devices / § 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.