HEEL OR ELBOW PROTECTOR
Device Facts
| Record ID | K812344 |
|---|---|
| Device Name | HEEL OR ELBOW PROTECTOR |
| Applicant | Fred Sammons, Inc. |
| Product Code | FMP · General Hospital |
| Decision Date | Sep 11, 1981 |
| 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).
