The following data is part of a premarket notification filed by Axiom Worldwide, Inc. with the FDA for Drx9000 True Spinal Decompression System.
| Device ID | K060735 |
| 510k Number | K060735 |
| Device Name: | DRX9000 TRUE SPINAL DECOMPRESSION SYSTEM |
| Classification | Equipment, Traction, Powered |
| Applicant | AXIOM WORLDWIDE, INC. 9423 CORPORATE LAKE DRIVE Tampa, FL 33634 |
| Contact | Jim Gibson |
| Correspondent | Tamas Borsai TUV RHEINLAND OF NORTH AMERICA, INC. 12 COMMERCE RD. Newton, CT 06470 |
| Product Code | ITH |
| CFR Regulation Number | 890.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-03-20 |
| Decision Date | 2006-05-26 |
| Summary: | summary |