DEVON COOL FACE
Device Facts
| Record ID | K760951 |
|---|---|
| Device Name | DEVON COOL FACE |
| Applicant | Devon Industries, Inc. |
| Product Code | KYR · General Hospital |
| Decision Date | Dec 30, 1976 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.6050 |
| Device Class | Class 1 |
Regulatory Classification
Identification
An ice bag is a device intended for medical purposes that is in the form of a container intended to be filled with ice that is used to apply dry cold therapy to an area of the body. The device may include a holder that keeps the bag in place against an external area of the patient.
