GroundRules
21 CFR 890.5160: Air-fluidized bed.
Where this section sits in the code
- 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
(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.
Collected 2026-08-27T02:24:47Z. Source file · JSON