RE-HEATER, HOT PACK
Device Facts
| Record ID | K863654 |
|---|---|
| Device Name | RE-HEATER, HOT PACK |
| Applicant | K & L Ent. |
| Product Code | IME · Physical Medicine |
| Decision Date | Oct 23, 1986 |
| 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.
