A3 ANKLE CPM UNIT
Device Facts
| Record ID | K945121 |
|---|---|
| Device Name | A3 ANKLE CPM UNIT |
| Applicant | Toronto Medical, Inc. |
| Product Code | BXB · Physical Medicine |
| Decision Date | Feb 17, 1995 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.5380 |
| Device Class | Class 1 |
Regulatory Classification
Identification
Powered exercise equipment consist of powered devices intended for medical purposes, such as to redevelop muscles or restore motion to joints or for use as an adjunct treatment for obesity. Examples include a powered treadmill, a powered bicycle, and powered parallel bars.
