Product code ITH
- Device name
- Equipment, Traction, Powered
- Medical specialty
- Physical Medicine
- Device class
- 2
- Regulation number
- 890.5900
- Review panel
- PM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243775 | True Non-Surgical Spinal Decompression System (DRX9000-SL) | Excite Medical of Tampa Bay, LLC | 2025-07-18 |
| K243366 | DRX9000C-SL Cervical Spinal Decompression System | Excite Medical of Tampa Bay, LLC | 2025-06-18 |
| K214037 | Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-Trac | Ergo-Flex Technologies, LLC | 2024-02-22 |
| K222912 | c1Trac | Zimmer Medizinsysteme GmbH | 2023-05-16 |
| K151640 | ELTRAC 471 | Enraf-Nonius, B.V. | 2015-10-16 |
| K150695 | Modpod | Hollywog, LLC | 2015-08-13 |
| K131983 | ITRAC CERVICAL TRACTION SYSTEM | Pivotal Health Solutions | 2014-09-10 |
| K130249 | INTEGRITY SPINAL CARE SYSTEM 3.0 | Integrity Life Sciences | 2014-02-06 |
| K112074 | EVERYWAY TRACTION UNIT, MODEL EVER-TRAC ET-800 | Everyway Medical Instruments Co.,Ltd | 2012-02-01 |
| K103248 | INTEGRITY SPINAL CARE SYSTEM | Integra Life Sciences | 2011-04-05 |
| K101889 | DECOMPRESSION OF CHOICE AND NEURO DECOMPRESSION DEVICE | Pivotal Health Solutions | 2010-08-27 |
| K091540 | MTD 4000 | Mettler Electronics Corp. | 2009-10-08 |
| K081247 | TM-400 | Ito Co., Ltd. | 2008-08-25 |
| K072064 | GRAVILAX TRACTION SYSTEM | Therapeutic Clinical Technologies, Inc. | 2008-04-21 |
| K073132 | MODEL D DISC FORCE | North American Medical Corp (Nam) | 2008-04-03 |
| K073542 | CYCLETRAC CT-5000 | Pt Products, LLC | 2008-02-14 |
| K071347 | VAX-D GENESIS G2 SYSTEM | Vax-D Medical Technologies, LLC | 2007-10-05 |
| K063353 | CTBOX CERVICAL/LUMBAR TRACTION | Circular Traction Supply, Inc. | 2007-03-14 |
| K060735 | DRX9000 TRUE SPINAL DECOMPRESSION SYSTEM | Axiom Worldwide, Inc. | 2006-05-26 |
| K053223 | TRITON/TRU-TRAC/TX/TRITON DTS TRACTION | Chattanooga Group | 2006-02-24 |
| K052453 | TRACTION SYSTEM, DIGIT-TRAC 930 | Ever Prosperous Instrument, Inc. | 2006-01-13 |
| K053503 | VAX-D GENESIS SYSTEM (THERAPEUTIC TABLE) | Vax-D Medical Technologies USA, L.C. | 2005-12-28 |
| K051938 | TRITON/TRU-TRAC/TX TRACTION DEVICES | Chattanooga Group | 2005-09-21 |
| K033231 | SPINA SYSTEM | North American Medical Corp (Nam) | 2005-09-09 |
| K051013 | SPINEMED S200B/S200C | Cert Health Sciences, LLC | 2005-04-27 |
| K042482 | BASS ANTALGIC-TRAK | Traction Masters, LLC | 2005-03-21 |
| K043239 | HEALTHSTAR ELITE | Hill Laboratories Co. | 2004-12-22 |
| K031996 | EXTENTRAC ELITE | Advanced Back Technologies | 2004-07-23 |
| K031862 | SPINERX-LDM | Spinerx Technology | 2003-10-31 |
| K031227 | LORDEX POWER TRACTION EQUIPMENT | Ever Prosperous Instrument, Inc. | 2003-07-17 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00860000487573 | Antalgic Trak | ANTALGIC-TRAK | 2024-07-11 |
| 04719871180297 | Everyway | EVERYWAY MEDICAL INSTRUMENTS CO., LTD. | 2023-08-24 |
| 04053815083344 | clTrac | Zimmer MedizinSysteme GmbH | 2023-06-05 |
| 00850020142408 | Decompression of Choice | PIVOTAL HEALTH SOLUTIONS, INC. | 2022-08-11 |
| 00850020142392 | Decompression of Choice | PIVOTAL HEALTH SOLUTIONS, INC. | 2022-08-11 |
| 00850020142385 | Decompression of Choice | PIVOTAL HEALTH SOLUTIONS, INC. | 2022-08-11 |
| 00850020142378 | Decompression of Choice | PIVOTAL HEALTH SOLUTIONS, INC. | 2022-08-11 |
| 00860000487504 | Antalgic Trak | ANTALGIC-TRAK | 2018-10-30 |
| 00852753008945 | iTrac | PIVOTAL HEALTH SOLUTIONS, INC. | 2018-10-16 |
| 00852753008952 | iTrac | PIVOTAL HEALTH SOLUTIONS, INC. | 2018-10-16 |
| M767S200U1 | SpineMED S200U Ultra Decompression System | Universal Pain Technology Canada Inc | 2017-07-07 |
| M767S200UC1 | SpineMED Decompression System | Universal Pain Technology Canada Inc | 2017-07-07 |
| 10660584000321 | Dynatron TX900+ Traction System | Dynatronics Corporation | 2016-09-24 |
| 10660584000451 | Dynatron SmarTRAC | Dynatronics Corporation | 2016-09-24 |
| 00853096004151 | Modpod | HOLLYWOG, LLC | 2016-09-20 |
| 00888912348904 | CHATTANOOGA | DJO, LLC | 2016-09-15 |
| 00888912348676 | CHATTANOOGA | DJO, LLC | 2016-09-15 |
| 00888912348669 | CHATTANOOGA | DJO, LLC | 2016-09-15 |
| 00888912348638 | CHATTANOOGA | DJO, LLC | 2016-09-15 |
| 00888912348621 | CHATTANOOGA | DJO, LLC | 2016-09-15 |
| 00888912025218 | CHATTANOOGA | DJO, LLC | 2016-09-15 |
| 00888912023962 | CHATTANOOGA | DJO, LLC | 2016-09-15 |
| 00888912023955 | CHATTANOOGA | DJO, LLC | 2016-09-15 |
| 00888912023825 | CHATTANOOGA | DJO, LLC | 2016-09-15 |
| 00888912022170 | CHATTANOOGA | DJO, LLC | 2016-09-15 |
| 00888912348652 | CHATTANOOGA | DJO, LLC | 2016-09-12 |
| M767S200B1 | SpineMED Decompression System | Universal Pain Technology Canada Inc | 2016-06-30 |
| M767S200C1 | SpineMED Decompression System | Universal Pain Technology Canada Inc | 2016-06-30 |
| M767S200E1 | SpineMED Decompression System | Universal Pain Technology Canada Inc | 2016-06-30 |
| M767S200EC1 | SpineMED Decompression System | Universal Pain Technology Canada Inc | 2016-06-30 |