CANVAS WEDGE
Device Facts
| Record ID | K790587 |
|---|---|
| Device Name | CANVAS WEDGE |
| Applicant | Maddak, Inc. |
| Product Code | IOD · Physical Medicine |
| Decision Date | Apr 3, 1979 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.5350 |
| Device Class | Class 1 |
Regulatory Classification
Identification
An exercise component is a device that is used in conjunction with other forms of exercise and that is intended for medical purposes, such as to redevelope muscles or restore motion to joints or for use as an adjunct treatment for obesity. Examples include weights, dumbbells, straps, and adaptive hand mitts.
