HOT OR COLD PACK (THERMIPAQ)
Device Facts
| Record ID | K921446 |
|---|---|
| Device Name | HOT OR COLD PACK (THERMIPAQ) |
| Applicant | Thermionics Corp. |
| Product Code | IME · Physical Medicine |
| Decision Date | Jul 13, 1992 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.5700 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A cold pack is a device intended for medical purposes that consists of a compact fabric envelope containing a specially hydrated pliable silicate gel capable of forming to the contour of the body and that provides cold therapy for body surfaces.
