Title 21: Food and Drugs
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/ PART 890 - PHYSICAL MEDICINE DEVICES
/ Subpart F - Physical Medicine Therapeutic Devices / § 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.