INSULATED THERMOELASTOMER MITT
Device Facts
| Record ID | K823622 |
|---|---|
| Device Name | INSULATED THERMOELASTOMER MITT |
| Applicant | Fred Sammons, Inc. |
| Product Code | IMA · Physical Medicine |
| Decision Date | Dec 30, 1982 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.5730 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A moist heat pack is a device intended for medical purposes that consists of silica gel in a fabric container used to retain an elevated temperature and that provides moist heat therapy for body surfaces.
