21 CFR § 878.4950 General and Plastic Surgery Devices

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

Current through Sep 8, 2026 · Read all of Part 878

(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]

← § 878.4930 Suture retention device.§ 878.4960 Operating tables and accessories and operating chairs and accessories. →