ITH — Equipment, Traction, Powered Class II
FDA product code ITH covers "Equipment, Traction, Powered", a Class II medical device regulated under 21 CFR 890.5900. Submissions are reviewed by the Physical Medicine panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- ITH
- Device Class
- Class II
- Regulation Number
- 890.5900
- Submission Type
- Review Panel
- PM
- Medical Specialty
- Physical Medicine
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K243775 | excite medical of tampa bay | True Non-Surgical Spinal Decompression System (DRX9000-SL) | July 18, 2025 |
| K243366 | excite medical of tampa bay | DRX9000C-SL Cervical Spinal Decompression System | June 18, 2025 |
| K214037 | ergo-flex technologies | Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-Trac | February 22, 2024 |
| K222912 | zimmer medizinsysteme | c1Trac | May 16, 2023 |
| K151640 | enraf-nonius | ELTRAC 471 | October 16, 2015 |
| K150695 | hollywog | Modpod | August 13, 2015 |
| K131983 | pivotal health solutions | ITRAC CERVICAL TRACTION SYSTEM | September 10, 2014 |
| K130249 | integrity life sciences | INTEGRITY SPINAL CARE SYSTEM 3.0 | February 6, 2014 |
| K112074 | everyway medical instruments co | EVERYWAY TRACTION UNIT, MODEL EVER-TRAC ET-800 | February 1, 2012 |
| K103248 | integra life sciences | INTEGRITY SPINAL CARE SYSTEM | April 5, 2011 |
| K101889 | pivotal health solutions | DECOMPRESSION OF CHOICE AND NEURO DECOMPRESSION DEVICE | August 27, 2010 |
| K091540 | mettler electronics | MTD 4000 | October 8, 2009 |
| K081247 | ito co | TM-400 | August 25, 2008 |
| K072064 | therapeutic clinical technologies | GRAVILAX TRACTION SYSTEM | April 21, 2008 |
| K073132 | north american medical corp (nam) | MODEL D DISC FORCE | April 3, 2008 |
| K073542 | pt products | CYCLETRAC CT-5000 | February 14, 2008 |
| K071347 | vax-d medical technologies | VAX-D GENESIS G2 SYSTEM | October 5, 2007 |
| K063353 | circular traction supply | CTBOX CERVICAL/LUMBAR TRACTION | March 14, 2007 |
| K060735 | axiom worldwide | DRX9000 TRUE SPINAL DECOMPRESSION SYSTEM | May 26, 2006 |
| K053223 | chattanooga group | TRITON/TRU-TRAC/TX/TRITON DTS TRACTION | February 24, 2006 |