21 CFR § 878.4960 General and Plastic Surgery Devices

§ 878.4960 Operating tables and accessories and operating chairs and accessories.

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

(a) Identification. Operating tables and accessories and operating chairs and accessories are AC-powered or air-powered devices, usually with movable components, intended for use during diagnostic examinations or surgical procedures to support and position a patient.

(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 § 878.9.

[55 FR 48440, Nov. 20, 1990, as amended at 65 FR 2318, Jan. 14, 2000]

← § 878.4950 Manual operating table and accessories and manual operating chair and accessories.§ 878.4961 Mountable electromechanical surgical system for transluminal approaches. →