21 C.F.R. § 890.5170 Powered flotation therapy bed.
Title 21 - Food and Drugs
(a) Identification. A powered flotation therapy bed is a device that is equipped with a mattress that contains a large volume of constantly moving water, air, mud, or sand. It is intended for medical purposes to treat or prevent a patient's bedsores, to treat severe or extensive burns, or to aid circulation. The mattress may be electrically heated. (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]
Title 21: Food and Drugs
PART 890—PHYSICAL MEDICINE DEVICES
Subpart F—Physical Medicine Therapeutic Devices
§ 890.5170 Powered flotation therapy bed.
