View all text of Subpart B [§ 888.1100 - § 888.1600]
§ 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.