Title 21: Food and Drugs
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/ PART 890 - PHYSICAL MEDICINE DEVICES
/ Subpart F - Physical Medicine Therapeutic Devices / § 890.5410 Powered finger exerciser.
§ 890.5410 Powered finger exerciser.
(a) Identification. A powered finger exerciser is a device intended for medical purposes to increase flexion and the extension range of motion of the joints of the second to the fifth fingers of the hand.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9.