DRX 2000
Device Facts
| Record ID | K010292 |
|---|---|
| Device Name | DRX 2000 |
| Applicant | Axiom Worldwide, Inc. |
| Product Code | ITH · Physical Medicine |
| Decision Date | May 1, 2001 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.5900 |
| Device Class | Class 2 |
Regulatory Classification
Identification
Powered traction equipment consists of powered devices intended for medical purposes for use in conjunction with traction accessories, such as belts and harnesses, to exert therapeutic pulling forces on the patient's body.