21 C.F.R. § 888.1520 Nonpowered goniometer.
Title 21 - Food and Drugs
(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]
Title 21: Food and Drugs
PART 888—ORTHOPEDIC DEVICES
Subpart B—Diagnostic Devices
§ 888.1520 Nonpowered goniometer.
