ENSWELL
Device Facts
| Record ID | K831899 |
|---|---|
| Device Name | ENSWELL |
| Applicant | Dr. Micheal A. Sabia |
| Product Code | IME · Physical Medicine |
| Decision Date | Jul 7, 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.
