§890.5180. Manual patient rotation bed.
21 C.F.R. § 890.5180
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.
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.
Notes, amendments, and revision history
Amendments
[48 FR 53047, Nov. 23, 1963, as amended at 65 FR 2322, Jan. 14, 2000]
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.
Source
Source: 48 FR 53047, Nov. 23, 1983, unless otherwise noted.
Amendments
[48 FR 53047, Nov. 23, 1963, as amended at 65 FR 2322, Jan. 14, 2000]