Title 21: Food and Drugs
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/ PART 890 - PHYSICAL MEDICINE DEVICES
/ Subpart F - Physical Medicine Therapeutic Devices / § 890.5160 Air-fluidized bed.
§ 890.5160 Air-fluidized bed.
(a) Identification. An air-fluidized bed is a device employing the circulation of filtered air through ceramic spherules (small, round ceramic objects) that is intended for medical purposes to treat or prevent bedsores, to treat severe or extensive burns, or 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.