The following data is part of a premarket notification filed by Axiom Worldwide, Inc. with the FDA for Drx 2000.
| Device ID | K010292 |
| 510k Number | K010292 |
| Device Name: | DRX 2000 |
| Classification | Equipment, Traction, Powered |
| Applicant | AXIOM WORLDWIDE, INC. 3830 GUNN HWY. Tampa, FL 33364 |
| Contact | Jim Gibson |
| Correspondent | Jim Gibson AXIOM WORLDWIDE, INC. 3830 GUNN HWY. Tampa, FL 33364 |
| Product Code | ITH |
| CFR Regulation Number | 890.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-01-31 |
| Decision Date | 2001-05-01 |