SENATEK
Device Facts
| Record ID | K822993 |
|---|---|
| Device Name | SENATEK |
| Applicant | American Health Tech., Inc. |
| Product Code | HST · Orthopedic |
| Decision Date | Oct 26, 1982 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.5850 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A nonpowered orthopedic traction apparatus is a device that consists of a rigid frame with nonpowered traction accessories, such as cords, pulleys, or weights, and that is intended to apply a therapeutic pulling force to the skeletal system.
