Title 21

SECTION 878.4950

878.4950 Manual operating table and accessories and manual operating chair and accessories.

§ 878.4950 Manual operating table and accessories and manual operating chair and accessories.

(a) Identification. A manual operating table and accessories and a manual operating chair and accessories are nonpowered devices, usually with movable components, intended to be used to support a patient during diagnostic examinations or surgical procedures.

(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 § 878.9.

[53 FR 23872, June 24, 1988, as amended at 54 FR 13828, Apr. 5, 1989; 59 FR 63010, Dec. 7, 1994; 66 FR 38803, July 25, 2001]

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