DEROYAL INDUSTRIES INFANT HEEL WARMER
Device Facts
| Record ID | K954716 |
|---|---|
| Device Name | DEROYAL INDUSTRIES INFANT HEEL WARMER |
| Applicant | Debusk Knitting Mills, Div. Deroyal Industries |
| Product Code | MPO · Physical Medicine |
| Decision Date | Jan 11, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.5710 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A hot or cold disposable pack is a device intended for medical purposes that consists of a sealed plastic bag incorporating chemicals that, upon activation, provides hot or cold therapy for body surfaces.
