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) | Jul 18, 2025 |
| K243366 | Excite Medical Of Tampa Bay | DRX9000C-SL Cervical Spinal Decompression System | Jun 18, 2025 |
| K214037 | Ergo-Flex Technologies | Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-Trac | Feb 22, 2024 |
| K222912 | Zimmer Medizinsysteme | c1Trac | May 16, 2023 |
| K151640 | Enraf-Nonius | ELTRAC 471 | Oct 16, 2015 |
| K150695 | Hollywog | Modpod | Aug 13, 2015 |
| K131983 | Pivotal Health Solutions | ITRAC CERVICAL TRACTION SYSTEM | Sep 10, 2014 |
| K130249 | Integrity Life Sciences | INTEGRITY SPINAL CARE SYSTEM 3.0 | Feb 6, 2014 |
| K112074 | Everyway Medical Instruments Co | EVERYWAY TRACTION UNIT, MODEL EVER-TRAC ET-800 | Feb 1, 2012 |
| K103248 | Integra Life Sciences | INTEGRITY SPINAL CARE SYSTEM | Apr 5, 2011 |
| K101889 | Pivotal Health Solutions | DECOMPRESSION OF CHOICE AND NEURO DECOMPRESSION DEVICE | Aug 27, 2010 |
| K091540 | Mettler Electronics | MTD 4000 | Oct 8, 2009 |
| K081247 | Ito Co | TM-400 | Aug 25, 2008 |
| K072064 | Therapeutic Clinical Technologies | GRAVILAX TRACTION SYSTEM | Apr 21, 2008 |
| K073132 | North American Medical Corp (Nam) | MODEL D DISC FORCE | Apr 3, 2008 |
| K073542 | Pt Products | CYCLETRAC CT-5000 | Feb 14, 2008 |
| K071347 | Vax-D Medical Technologies | VAX-D GENESIS G2 SYSTEM | Oct 5, 2007 |
| K063353 | Circular Traction Supply | CTBOX CERVICAL/LUMBAR TRACTION | Mar 14, 2007 |
| K060735 | Axiom Worldwide | DRX9000 TRUE SPINAL DECOMPRESSION SYSTEM | May 26, 2006 |
| K053223 | Chattanooga Group | TRITON/TRU-TRAC/TX/TRITON DTS TRACTION | Feb 24, 2006 |