Title 21: Food and Drugs
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/ PART 888 - ORTHOPEDIC DEVICES
/ Subpart B - Diagnostic Devices / § 888.1520 Nonpowered goniometer.
§ 888.1520 Nonpowered goniometer.
(a) Identification. A nonpowered goniometer is a mechanical device intended for medical purposes to measure the range of motion of joints.
(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 § 888.9.