21 CFR 890.5410 — Exerciser, Finger, Powered

Physical Medicine (PM) · Part 890 Subpart F—Physical Medicine Therapeutic Devices · § 890.5410

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.

Classification Rationale

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.

Product Codes

Product CodeDevice NameClassDevicesAttributes
JFAExerciser, Finger, Powered112
Innolitics

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