§ 890.5180. Manual patient rotation bed.
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/us/cfr/t21/s§ 890.5180·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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]