21 CFR 882.1700 - Percussor.

§ 882.1700 Percussor.

(a)Identification. A percussor is a small hammerlike device used by a physician to provide light blows to a body part. A percussor is used as a diagnostic aid during physical examinations.

(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, 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; 59 FR 63011, Dec. 7, 1994; 66 FR 38807, July 25, 2001]

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