CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 890—PHYSICAL MEDICINE DEVICES > SUBPART F—Physical Medicine Therapeutic Devices (§890.5050 to §890.5975) > 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.

Code of Federal Regulations

[48 FR 53047, Nov. 23, 1963, as amended at 65 FR 2322, Jan. 14, 2000]