THERMAFLEX, MODEL SD 55 C.P.M.H.
Device Facts
| Record ID | K945803 |
|---|---|
| Device Name | THERMAFLEX, MODEL SD 55 C.P.M.H. |
| Applicant | Burke Neutech, Inc. |
| Product Code | JFA · Physical Medicine |
| Decision Date | May 11, 1995 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.5410 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A powered finger exerciser is a device intended for medical purposes to increase flexion and the extension range of motion of the joints of the second to the fifth fingers of the hand.