PROTECT IV GARD
Device Facts
| Record ID | K772060 |
|---|---|
| Device Name | PROTECT IV GARD |
| Applicant | Omnicon Medical Corp. |
| Product Code | FMP · General Hospital |
| Decision Date | Dec 20, 1977 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.6450 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A skin pressure protector is a device intended for medical purposes that is used to reduce pressure on the skin over a bony prominence to reduce the likelihood of the patient's developing decubitus ulcers (bedsores).