HEEL/ELBOW PROTECTORS
Device Facts
| Record ID | K791709 |
|---|---|
| Device Name | HEEL/ELBOW PROTECTORS |
| Applicant | Fibre Formations, Inc. |
| Product Code | FMP · General Hospital |
| Decision Date | Sep 24, 1979 |
| 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).
