FDA Product Code
FDA Product Code ITH — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Physical Medicine
- 21 CFR Citation
- 890.5900
510(k) Clearances — 71 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K243775 | True Non-Surgical Spinal Decompression System (DRX9000-SL) | Excite Medical of Tampa Bay, LLC | 2025-07-18 | Traditional | PDF ↗ |
| K243366 | DRX9000C-SL Cervical Spinal Decompression System | Excite Medical of Tampa Bay, LLC | 2025-06-18 | Traditional | PDF ↗ |
| K214037 | Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-Trac | Ergo-Flex Technologies, LLC | 2024-02-22 | Traditional | PDF ↗ |
| K222912 | c1Trac | Zimmer Medizinsysteme GmbH | 2023-05-16 | Traditional | PDF ↗ |
| K151640 | ELTRAC 471 | Enraf-Nonius, B.V. | 2015-10-16 | Traditional | PDF ↗ |
| K150695 | Modpod | Hollywog, LLC | 2015-08-13 | Traditional | PDF ↗ |
| K131983 | ITRAC CERVICAL TRACTION SYSTEM | Pivotal Health Solutions | 2014-09-10 | Traditional | PDF ↗ |
| K130249 | INTEGRITY SPINAL CARE SYSTEM 3.0 | Integrity Life Sciences | 2014-02-06 | Traditional | PDF ↗ |
| K112074 | EVERYWAY TRACTION UNIT, MODEL EVER-TRAC ET-800 | Everyway Medical Instruments Co.,Ltd | 2012-02-01 | Traditional | PDF ↗ |
| K103248 | INTEGRITY SPINAL CARE SYSTEM | Integra Life Sciences | 2011-04-05 | Traditional | PDF ↗ |
| K101889 | DECOMPRESSION OF CHOICE AND NEURO DECOMPRESSION DEVICE | Pivotal Health Solutions | 2010-08-27 | Traditional | PDF ↗ |
| K091540 | MTD 4000 | Mettler Electronics Corp. | 2009-10-08 | Abbreviated | PDF ↗ |
| K081247 | TM-400 | Ito Co., Ltd. | 2008-08-25 | Traditional | PDF ↗ |
| K072064 | GRAVILAX TRACTION SYSTEM | Therapeutic Clinical Technologies, Inc. | 2008-04-21 | Traditional | PDF ↗ |
| K073132 | MODEL D DISC FORCE | North American Medical Corp (Nam) | 2008-04-03 | Traditional | PDF ↗ |
| K073542 | CYCLETRAC CT-5000 | Pt Products, LLC | 2008-02-14 | Traditional | PDF ↗ |
| K071347 | VAX-D GENESIS G2 SYSTEM | Vax-D Medical Technologies, LLC | 2007-10-05 | Traditional | PDF ↗ |
| K063353 | CTBOX CERVICAL/LUMBAR TRACTION | Circular Traction Supply, Inc. | 2007-03-14 | Traditional | PDF ↗ |
| K060735 | DRX9000 TRUE SPINAL DECOMPRESSION SYSTEM | Axiom Worldwide, Inc. | 2006-05-26 | Traditional | PDF ↗ |
| K053223 | TRITON/TRU-TRAC/TX/TRITON DTS TRACTION | Chattanooga Group | 2006-02-24 | Traditional | PDF ↗ |
| K052453 | TRACTION SYSTEM, DIGIT-TRAC 930 | Ever Prosperous Instrument, Inc. | 2006-01-13 | Traditional | PDF ↗ |
| K053503 | VAX-D GENESIS SYSTEM (THERAPEUTIC TABLE) | Vax-D Medical Technologies USA, L.C. | 2005-12-28 | Traditional | PDF ↗ |
| K051938 | TRITON/TRU-TRAC/TX TRACTION DEVICES | Chattanooga Group | 2005-09-21 | Traditional | PDF ↗ |
| K033231 | SPINA SYSTEM | North American Medical Corp (Nam) | 2005-09-09 | Traditional | PDF ↗ |
| K051013 | SPINEMED S200B/S200C | Cert Health Sciences, LLC | 2005-04-27 | Traditional | PDF ↗ |
| K042482 | BASS ANTALGIC-TRAK | Traction Masters, LLC | 2005-03-21 | Traditional | PDF ↗ |
| K043239 | HEALTHSTAR ELITE | Hill Laboratories Co. | 2004-12-22 | Traditional | PDF ↗ |
| K031996 | EXTENTRAC ELITE | Advanced Back Technologies | 2004-07-23 | Abbreviated | PDF ↗ |
| K031862 | SPINERX-LDM | Spinerx Technology | 2003-10-31 | Traditional | PDF ↗ |
| K031227 | LORDEX POWER TRACTION EQUIPMENT | Ever Prosperous Instrument, Inc. | 2003-07-17 | Traditional | PDF ↗ |
| K030060 | SPINEMED | Cert Health Sciences, LLC | 2003-02-05 | Traditional | PDF ↗ |
| K022602 | DRX3000 | Axiom Usa., Inc. | 2003-01-23 | Traditional | PDF ↗ |
| K023160 | DRX5000 | Axiom Usa., Inc. | 2002-12-20 | Traditional | PDF ↗ |
| K010292 | DRX 2000 | Axiom Worldwide, Inc. | 2001-05-01 | Traditional | PDF ↗ |
| K001712 | 3D ACTIVETRAC | The Saunders Group | 2000-08-31 | Traditional | PDF ↗ |
| K002260 | SPINA SYSTEM | North American Medical Corporation (Nam) | 2000-08-25 | Traditional | PDF ↗ |
| K001361 | JILCO TRACTION-FLEXION CHAIR | Jilco Enterprises | 2000-07-19 | Traditional | PDF ↗ |
| K001296 | SPINAL CORD AND IMMOBILIZATION TRACTION SYSTEM | Cavendish Scott, Inc. | 2000-07-17 | Traditional | PDF ↗ |
| K001401 | AMT THERAPEUTIC TABLE, MODEL 748AMT | Amt Mfg., Inc. | 2000-07-12 | Traditional | PDF ↗ |
| K993919 | DYNATRON 900 | Dynatronics Corp. | 2000-01-03 | Traditional | PDF ↗ |
| K991835 | HANG UPS POWER II | Stl Intl., Inc. | 1999-12-20 | Traditional | PDF ↗ |
| K992733 | AKRON ATP9 TRACTION MACHINE | Huntleigh Technology, Inc. | 1999-11-10 | Traditional | PDF ↗ |
| K992545 | TM-300 TRACTION SYSTEM | Ito Co., Ltd. | 1999-09-01 | Traditional | PDF ↗ |
| K991931 | CTD MARK I TRACTION DEVICE | Therasys, Inc. | 1999-08-12 | Traditional | PDF ↗ |
| K981822 | DRS SYSTEM | Professional Distribution Systems, Inc. | 1998-06-24 | Traditional | PDF ↗ |
| K951622 | VAX-D THERAPEUTIC TABLE | Vat-Tech, Inc. | 1996-07-02 | Traditional | PDF ↗ |
| K944699 | ATT-300 | Health Care Mfg., Inc. | 1995-05-26 | Traditional | PDF ↗ |
| K951228 | ASH-7000 | U.S. Table, Inc. | 1995-05-17 | Traditional | PDF ↗ |
| K940200 | EXCEL TX | Excel Tech. , Ltd. | 1994-06-07 | Traditional | PDF ↗ |
| K940590 | MINTO SKIN TRACTION MOTOR | Minto Research & Development, Inc. | 1994-04-15 | Traditional | PDF ↗ |
| K930691 | ACCUTRAC TRACTION UNIT | I-Rep, Inc. | 1993-07-22 | Traditional | PDF ↗ |
| K923103 | JT-1 POWERED TRACTION UNIT | Chirotronics, Inc. | 1992-11-09 | Traditional | PDF ↗ |
| K900575 | ULTRA-TRAC | Practical Healthcare Devices, Inc. | 1990-05-29 | Traditional | PDF ↗ |
| K900475 | DISTRAC(TM) TABLE | Lossing Orthopedic, Inc. | 1990-05-24 | Traditional | PDF ↗ |
| K894435 | VAX-T PELVIC TRACTION BELT | Vat-Tech, Inc. | 1989-08-03 | Traditional | PDF ↗ |
| K893448 | TRU TRAC TRACTION TABLE | Tru-Trac | 1989-06-09 | Traditional | PDF ↗ |
| K893168 | SPINALATOR JS-1100 TRACTION UNIT | The Spinalator Co. | 1989-05-26 | Traditional | PDF ↗ |
| K881603 | ULTRA TRACTION | Component Equipment Mfg., Inc. | 1988-05-04 | Traditional | PDF ↗ |
| K872780 | GUS TRAC C-303 | Gus Company, Inc. | 1987-10-06 | Traditional | PDF ↗ |
| K862846 | TEC VARI-TRAC II TRACTION UNIT | Therapeutic Equipment Corp. | 1986-08-07 | Traditional | PDF ↗ |
| K862579 | TRU-TRAC 3-DIMENSIONAL CERVICAL TRACTION-TD-9000 | Tru-Trac | 1986-08-06 | Traditional | PDF ↗ |
| K861832 | RICH-MAR SPINA-MOBILIZOR | Rich-Mar Corp. | 1986-06-27 | Traditional | PDF ↗ |
| K860227 | POWERED TRACTION EQUIPMENT | R. P. Hood, Inc. | 1986-02-06 | Traditional | PDF ↗ |
| K844385 | ESCOTEK EST TRAC 401 | Nor-Am Patient Care Products, Inc. | 1985-05-01 | Traditional | PDF ↗ |
| K843522 | DONWAY SPLINT | Australian Biomedical Corporation , Ltd. | 1985-02-07 | Traditional | PDF ↗ |
| K843581 | PROM NAID | Lossing Orthopedic, Inc. | 1984-12-11 | Traditional | PDF ↗ |
| K834405 | TEC TRACTION MACHINE | Akron Medical Corp. | 1984-01-13 | Traditional | PDF ↗ |
| K830088 | TRACTION 230 | Tri W-G, Inc. | 1983-01-24 | Traditional | PDF ↗ |
| K821002 | INVERCHAIR | Inverchair Marketing, Inc. | 1982-06-22 | Traditional | PDF ↗ |
| K772154 | CERVICAL TRACTION DIV., PNEUMATIC | Jobst | 1977-11-30 | Traditional | PDF ↗ |
| K770610 | TABLE, TREATMENT & TRACTION, HI-LO | Will Ross Co. | 1977-04-08 | Traditional | PDF ↗ |
Product code ITH · Class II · Physical Medicine. Data: openFDA.