CONTEX
Device Facts
| Record ID | K790995 |
|---|---|
| Device Name | CONTEX |
| Applicant | Foam Tek, Inc. |
| Product Code | FMP · General Hospital |
| Decision Date | Jun 11, 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).
