ZERO-G(TM) GEL/FOAM MATTRESS TOPPER
Device Facts
| Record ID | K911843 |
|---|---|
| Device Name | ZERO-G(TM) GEL/FOAM MATTRESS TOPPER |
| Applicant | Steridyne Corp. |
| Product Code | KIC · Physical Medicine |
| Decision Date | May 30, 1991 |
| 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.
