(a) Identification. A goniometer is an AC-powered or battery powered device intended to evaluate joint function by measuring and recording ranges of motion, acceleration, or forces exerted by a joint.
(b) Classification. (1) Class I (general controls) for a goniometer that does not use electrode lead wires and patient cables. This device is exempt from the premarket notification procedures of subpart E of part 807 of this chapter subject to Sec. 888.9.
(1) Class I (general controls) for a goniometer that does not use electrode lead wires and patient cables. This device is exempt from the premarket notification procedures of subpart E of part 807 of this chapter subject to Sec. 888.9.
(2) Class II (special controls) for a goniometer that uses electrode lead wires and patient cables. The special controls consist of:
(i) The performance standard under part 898 of this chapter, and
(ii) The guidance entitled ``Guidance on the Performance Standard for Electrode Lead Wires and Patient Cables.'' This device is exempt from the premarket notification procedures of subpart E of part 807 of this chapter subject to Sec. 888.9. [65 FR 19319, Apr. 11, 2000]