REM-AIR
Device Facts
| Record ID | K924686 |
|---|---|
| Device Name | REM-AIR |
| Applicant | Mellenair Ent., Inc. |
| Product Code | INX · Physical Medicine |
| Decision Date | Feb 12, 1993 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.5160 |
| Device Class | Class 2 |
Regulatory Classification
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.
Special Controls
*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.
