SOF. CARE CUSHION & SOF-CARE CUSHION COVER
Device Facts
| Record ID | K851027 |
|---|---|
| Device Name | SOF. CARE CUSHION & SOF-CARE CUSHION COVER |
| Applicant | Gaymar Industries, Inc. |
| Product Code | KIC · Physical Medicine |
| Decision Date | Jun 18, 1985 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.3175 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A flotation cushion is a device intended for medical purposes that is made of plastic, rubber, or other type of covering, that is filled with water, air, gel, mud, or any other substance allowing a flotation media, used on a seat to lessen the likelihood of skin ulcers.
