SCM-3 AND ACCESSORIES
Device Facts
| Record ID | K914921 |
|---|---|
| Device Name | SCM-3 AND ACCESSORIES |
| Applicant | Gaymar Industries, Inc. |
| Product Code | IKY · General Hospital |
| Decision Date | Mar 12, 1992 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.5150 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A nonpowered flotation therapy mattress is a mattress intended for medical purposes which contains air, fluid, or other materials that have the functionally equivalent effect of supporting a patient and avoiding excess pressure on local body areas. The device is intended to treat or prevent decubitus ulcers (bed sores).
