TRANSWARMER
Device Facts
| Record ID | K934631 |
|---|---|
| Device Name | TRANSWARMER |
| Applicant | Prism Technologies, Inc. |
| Product Code | IMD · Physical Medicine |
| Decision Date | Feb 3, 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.
