ICY COLD ICE CAP
Device Facts
| Record ID | K830416 |
|---|---|
| Device Name | ICY COLD ICE CAP |
| Applicant | Ladora Ent. |
| Product Code | IME · Physical Medicine |
| Decision Date | Mar 10, 1983 |
| 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.
