FDA 510(k) Applications for Medical Device Product Code "ITH"
(Equipment, Traction, Powered)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K031996 | ADVANCED BACK TECHNOLOGIES | EXTENTRAC ELITE | 07/23/2004 |
| K001401 | AMT MFG., INC. | AMT THERAPEUTIC TABLE, MODEL 748AMT | 07/12/2000 |
| K022602 | AXIOM USA. INC | DRX3000 | 01/23/2003 |
| K023160 | AXIOM USA. INC | DRX5000 | 12/20/2002 |
| K010292 | AXIOM WORLDWIDE, INC. | DRX 2000 | 05/01/2001 |
| K060735 | AXIOM WORLDWIDE, INC. | DRX9000 TRUE SPINAL DECOMPRESSION SYSTEM | 05/26/2006 |
| K001296 | CAVENDISH SCOTT, INC. | SPINAL CORD AND IMMOBILIZATION TRACTION SYSTEM | 07/17/2000 |
| K030060 | CERT HEALTH SCIENCES, LLC | SPINEMED | 02/05/2003 |
| K051013 | CERT HEALTH SCIENCES, LLC | SPINEMED S200B/S200C | 04/27/2005 |
| K051938 | CHATTANOOGA GROUP | TRITON/TRU-TRAC/TX TRACTION DEVICES | 09/21/2005 |
| K053223 | CHATTANOOGA GROUP | TRITON/TRU-TRAC/TX/TRITON DTS TRACTION | 02/24/2006 |
| K063353 | CIRCULAR TRACTION SUPPLY, INC. | CTBOX CERVICAL/LUMBAR TRACTION | 03/14/2007 |
| K993919 | DYNATRONICS CORP. | DYNATRON 900 | 01/03/2000 |
| K151640 | ENRAF-NONIUS B.V. | ELTRAC 471 | 10/16/2015 |
| K031227 | EVER PROSPEROUS INSTRUMENT INC | LORDEX POWER TRACTION EQUIPMENT | 07/17/2003 |
| K052453 | EVER PROSPEROUS INSTRUMENT, INC. | TRACTION SYSTEM, DIGIT-TRAC 930 | 01/13/2006 |
| K112074 | EVERYWAY MEDICAL INSTRUMENTS CO., LTD. | EVERYWAY TRACTION UNIT, MODEL EVER-TRAC ET-800 | 02/01/2012 |
| K043239 | HILL LABORATORIES CO. | HEALTHSTAR ELITE | 12/22/2004 |
| K150695 | HOLLYWOG, LLC | Modpod | 08/13/2015 |
| K992733 | HUNTLEIGH TECHNOLOGY, INC. | AKRON ATP9 TRACTION MACHINE | 11/10/1999 |
| K103248 | INTEGRA LIFE SCIENCES | INTEGRITY SPINAL CARE SYSTEM | 04/05/2011 |
| K130249 | INTEGRITY LIFE SCIENCES | INTEGRITY SPINAL CARE SYSTEM 3.0 | 02/06/2014 |
| K992545 | ITO CO., LTD. | TM-300 TRACTION SYSTEM | 09/01/1999 |
| K081247 | ITO CO., LTD. | TM-400 | 08/25/2008 |
| K001361 | JILCO ENTERPRISES | JILCO TRACTION-FLEXION CHAIR | 07/19/2000 |
| K091540 | METTLER ELECTRONICS CORP. | MTD 4000 | 10/08/2009 |
| K073132 | NORTH AMERICAN MEDICAL CORP (NAM) | MODEL D DISC FORCE | 04/03/2008 |
| K033231 | NORTH AMERICAN MEDICAL CORP (NAM) | SPINA SYSTEM | 09/09/2005 |
| K002260 | NORTH AMERICAN MEDICAL CORPORATION (NAM) | SPINA SYSTEM | 08/25/2000 |
| K101889 | PIVOTAL HEALTH SOLUTIONS | DECOMPRESSION OF CHOICE AND NEURO DECOMPRESSION DEVICE | 08/27/2010 |
| K131983 | PIVOTAL HEALTH SOLUTIONS | ITRAC CERVICAL TRACTION SYSTEM | 09/10/2014 |
| K981822 | PROFESSIONAL DISTRIBUTION SYSTEMS, INC. | DRS SYSTEM | 06/24/1998 |
| K073542 | PT PRODUCTS, LLC | CYCLETRAC CT-5000 | 02/14/2008 |
| K031862 | SPINERX TECHNOLOGY | SPINERX-LDM | 10/31/2003 |
| K991835 | STL INTL., INC. | HANG UPS POWER II | 12/20/1999 |
| K001712 | THE SAUNDERS GROUP | 3D ACTIVETRAC | 08/31/2000 |
| K072064 | THERAPEUTIC CLINICAL TECHNOLOGIES, INC. | GRAVILAX TRACTION SYSTEM | 04/21/2008 |
| K991931 | THERASYS, INC. | CTD MARK I TRACTION DEVICE | 08/12/1999 |
| K042482 | TRACTION MASTERS, L.L.C. | BASS ANTALGIC-TRAK | 03/21/2005 |
| K951622 | VAT-TECH, INC. | VAX-D THERAPEUTIC TABLE | 07/02/1996 |
| K071347 | VAX-D MEDICAL TECHNOLOGIES LLC | VAX-D GENESIS G2 SYSTEM | 10/05/2007 |
| K053503 | VAX-D MEDICAL TECHNOLOGIES USA, L.C. | VAX-D GENESIS SYSTEM (THERAPEUTIC TABLE) | 12/28/2005 |
| K222912 | Zimmer MedizinSysteme GmbH | c1Trac | 05/16/2023 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
