21 CFR 890.5180 - Manual patient rotation bed.

§ 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]

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United States Code