§ 882.1525 Tuning fork.
(a) Identification. A tuning fork is a mechanical device which resonates at a given frequency and is used to diagnose hearing disorders and to test for vibratory sense.
(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 § 882.9. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
[44 FR 51730, Sept. 4, 1979, as amended at 54 FR 25051, June 12, 1989; 66 FR 38807, July 25, 2001; 90 FR 55989, Dec. 4, 2025]