Current through September 30, 2024
Section 890.5170 - Powered flotation therapy bed(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