21 CFR 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.

[ 48 FR 53047, Nov. 23, 1983, as amended at 61 FR 1125, Jan. 16, 1996; 66 FR 38818, July 25, 2001]

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United States Code