§890.5225. Powered patient rotation bed.
21 C.F.R. § 890.5225
Identification. A powered 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, urinary tract blockage, and to aid circulation.
Classification. Class II (special 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, 1983, as amended at 63 FR 59231, Nov. 3, 1998]
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, 1983, as amended at 63 FR 59231, Nov. 3, 1998]