Code of Federal Regulations (Last Updated: May 6, 2024) |
Title 21 - Food and Drugs |
Chapter I - Food and Drug Administration, Department of Health and Human Services |
SubChapter H - Medical Devices |
Part 890 - Physical Medicine Devices |
Subpart F - Physical Medicine Therapeutic Devices |
§ 890.5180 - Manual patient rotation bed.
Latest version.
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§ 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]