§ 888.1520. Nonpowered goniometer.
67 words·~1 min read·
/us/cfr/t21/s§ 888.1520·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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. [52 FR 33702, Sept. 4, 1987, as amended at 66 FR 38815, July 25, 2001]