Section 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 system regulation in part 820 of this chapter, of this chapter, with the exception of § 820.180 , with respect to general requirements concerning records, and § 820.198 , with respect to complaint files.44 FR 51730, Sept. 4, 1979, as amended at 54 FR 25051, June 12, 1989; 66 FR 38807 , July 25, 2001