PULMONEX DYNAMIC AIR THERAPY UNIT
Device Facts
| Record ID | K950756 |
|---|---|
| Device Name | PULMONEX DYNAMIC AIR THERAPY UNIT |
| Applicant | Hill-Rom, Inc. |
| Product Code | IKZ · Physical Medicine |
| Decision Date | May 30, 1995 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.5225 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A powered patient rotation bed is a device that turns a patient who is restricted to a reclining position. It is intended for medical purposes to treat or prevent bedsores, to treat severe and extensive burns, urinary tract blockage, and 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.
