OMNI COLD GEL PACKS
Device Facts
| Record ID | K954877 |
|---|---|
| Device Name | OMNI COLD GEL PACKS |
| Applicant | Omni Therm, Inc. |
| Product Code | IMD · Physical Medicine |
| Decision Date | Feb 13, 1996 |
| Decision | SN |
| 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.
