Current through November 30, 2024
Section 890.5180 - Manual patient rotation bed(a)Identification. A manual patient rotation bed is a device that turns a patient who is restricted to a reclining position. It is intended for medical purposes to treat or prevent bedsores, to treat severe and extensive burns, or to aid circulation.(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 § 890.9 .48 FR 53047, Nov. 23, 1963, as amended at 65 FR 2322 , Jan. 14, 2000