EARETTE HEARING AID SEARS #8054
Device Facts
| Record ID | K810379 |
|---|---|
| Device Name | EARETTE HEARING AID SEARS #8054 |
| Applicant | Oticon Corp. |
| Product Code | FSD · General Hospital |
| Decision Date | Mar 4, 1981 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.5160 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A therapeutic medical binder is a device, usually made of cloth, that is intended for medical purposes and that can be secured by ties so that it supports the underlying part of the body or holds a dressing in place. This generic type of device includes the abdominal binder, breast binder, and perineal binder.