OMNI WARM GEL PACKS
Device Facts
| Record ID | K936084 |
|---|---|
| Device Name | OMNI WARM GEL PACKS |
| Applicant | Omni Therm, Inc. |
| Product Code | IMD · Physical Medicine |
| Decision Date | Mar 31, 1994 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.5710 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A hot or cold disposable pack is a device intended for medical purposes that consists of a sealed plastic bag incorporating chemicals that, upon activation, provides hot or cold therapy for body surfaces.
