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e-CFR data is current as of January 19, 2021

Title 21Chapter ISubchapter HPart 890Subpart F → §890.5225


Title 21: Food and Drugs
PART 890—PHYSICAL MEDICINE DEVICES
Subpart F—Physical Medicine Therapeutic Devices


§890.5225   Powered patient rotation bed.

(a) 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.

(b) 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.

[48 FR 53047, Nov. 23, 1983, as amended at 63 FR 59231, Nov. 3, 1998]

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