21 C.F.R. § 880.5120

Current through October 31, 2024
Section 880.5120 - Manual adjustable hospital bed
(a)Identification. A manual adjustable hospital bed is a device intended for medical purposes that consists of a bed with a manual mechanism operated by an attendant to adjust the height and surface contour of the bed. The device includes movable and latchable side rails.
(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 § 880.9 . 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.

21 C.F.R. §880.5120

45 FR 69682, Oct. 21, 1980, as amended at 54 FR 25050, June 12, 1989; 66 FR 38804 , July 25, 2001