ITH
71 FDA 510(k) clearances · Product code
90 daysmedian time to decision
245 days90th percentile
71clearances measured
FDA profile
- Official device name
- Equipment, Traction, Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5900
- Medical specialty
- Physical Medicine
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 2002: 1 · 2005: 2 · 2006: 3 · 2007: 2 · 2009: 3 · 2011: 5
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| True Non-Surgical Spinal Decompression System (DRX9000-SL) (K243775) | Excite Medical of Tampa Bay, LLC | 2025-07-18 |
| DRX9000C-SL Cervical Spinal Decompression System (K243366) | Excite Medical of Tampa Bay, LLC | 2025-06-18 |
| Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-Trac (K214037) | Ergo-Flex Technologies, LLC | 2024-02-22 |
| c1Trac (K222912) | Zimmer Medizinsysteme GmbH | 2023-05-16 |
| ELTRAC 471 (K151640) | Enraf-Nonius, B.V. | 2015-10-16 |
| Modpod (K150695) | Hollywog, LLC | 2015-08-13 |
| ITRAC CERVICAL TRACTION SYSTEM (K131983) | Pivotal Health Solutions | 2014-09-10 |
| INTEGRITY SPINAL CARE SYSTEM 3.0 (K130249) | Integrity Life Sciences | 2014-02-06 |
| EVERYWAY TRACTION UNIT, MODEL EVER-TRAC ET-800 (K112074) | Everyway Medical Instruments Co.,Ltd | 2012-02-01 |
| INTEGRITY SPINAL CARE SYSTEM (K103248) | Integra Life Sciences | 2011-04-05 |
| DECOMPRESSION OF CHOICE AND NEURO DECOMPRESSION DEVICE (K101889) | Pivotal Health Solutions | 2010-08-27 |
| MTD 4000 (K091540) | Mettler Electronics Corp. | 2009-10-08 |
| TM-400 (K081247) | Ito Co., Ltd. | 2008-08-25 |
| GRAVILAX TRACTION SYSTEM (K072064) | Therapeutic Clinical Technologies, Inc. | 2008-04-21 |
| MODEL D DISC FORCE (K073132) | North American Medical Corp (Nam) | 2008-04-03 |
| CYCLETRAC CT-5000 (K073542) | Pt Products, LLC | 2008-02-14 |
| VAX-D GENESIS G2 SYSTEM (K071347) | Vax-D Medical Technologies, LLC | 2007-10-05 |
| CTBOX CERVICAL/LUMBAR TRACTION (K063353) | Circular Traction Supply, Inc. | 2007-03-14 |
| DRX9000 TRUE SPINAL DECOMPRESSION SYSTEM (K060735) | Axiom Worldwide, Inc. | 2006-05-26 |
| TRITON/TRU-TRAC/TX/TRITON DTS TRACTION (K053223) | Chattanooga Group | 2006-02-24 |
| TRACTION SYSTEM, DIGIT-TRAC 930 (K052453) | Ever Prosperous Instrument, Inc. | 2006-01-13 |
| VAX-D GENESIS SYSTEM (THERAPEUTIC TABLE) (K053503) | Vax-D Medical Technologies USA, L.C. | 2005-12-28 |
| TRITON/TRU-TRAC/TX TRACTION DEVICES (K051938) | Chattanooga Group | 2005-09-21 |
| SPINA SYSTEM (K033231) | North American Medical Corp (Nam) | 2005-09-09 |
| SPINEMED S200B/S200C (K051013) | Cert Health Sciences, LLC | 2005-04-27 |
| BASS ANTALGIC-TRAK (K042482) | Traction Masters, LLC | 2005-03-21 |
| HEALTHSTAR ELITE (K043239) | Hill Laboratories Co. | 2004-12-22 |
| EXTENTRAC ELITE (K031996) | Advanced Back Technologies | 2004-07-23 |
| SPINERX-LDM (K031862) | Spinerx Technology | 2003-10-31 |
| LORDEX POWER TRACTION EQUIPMENT (K031227) | Ever Prosperous Instrument, Inc. | 2003-07-17 |
| SPINEMED (K030060) | Cert Health Sciences, LLC | 2003-02-05 |
| DRX3000 (K022602) | Axiom Usa., Inc. | 2003-01-23 |
| DRX5000 (K023160) | Axiom Usa., Inc. | 2002-12-20 |
| DRX 2000 (K010292) | Axiom Worldwide, Inc. | 2001-05-01 |
| 3D ACTIVETRAC (K001712) | The Saunders Group | 2000-08-31 |
| SPINA SYSTEM (K002260) | North American Medical Corporation (Nam) | 2000-08-25 |
| JILCO TRACTION-FLEXION CHAIR (K001361) | Jilco Enterprises | 2000-07-19 |
| SPINAL CORD AND IMMOBILIZATION TRACTION SYSTEM (K001296) | Cavendish Scott, Inc. | 2000-07-17 |
| AMT THERAPEUTIC TABLE, MODEL 748AMT (K001401) | Amt Mfg., Inc. | 2000-07-12 |
| DYNATRON 900 (K993919) | Dynatronics Corp. | 2000-01-03 |
| HANG UPS POWER II (K991835) | Stl Intl., Inc. | 1999-12-20 |
| AKRON ATP9 TRACTION MACHINE (K992733) | Huntleigh Technology, Inc. | 1999-11-10 |
| TM-300 TRACTION SYSTEM (K992545) | Ito Co., Ltd. | 1999-09-01 |
| CTD MARK I TRACTION DEVICE (K991931) | Therasys, Inc. | 1999-08-12 |
| DRS SYSTEM (K981822) | Professional Distribution Systems, Inc. | 1998-06-24 |
| VAX-D THERAPEUTIC TABLE (K951622) | Vat-Tech, Inc. | 1996-07-02 |
| ATT-300 (K944699) | Health Care Mfg., Inc. | 1995-05-26 |
| ASH-7000 (K951228) | U.S. Table, Inc. | 1995-05-17 |
| EXCEL TX (K940200) | Excel Tech. , Ltd. | 1994-06-07 |
| MINTO SKIN TRACTION MOTOR (K940590) | Minto Research & Development, Inc. | 1994-04-15 |
| ACCUTRAC TRACTION UNIT (K930691) | I-Rep, Inc. | 1993-07-22 |
| JT-1 POWERED TRACTION UNIT (K923103) | Chirotronics, Inc. | 1992-11-09 |
| ULTRA-TRAC (K900575) | Practical Healthcare Devices, Inc. | 1990-05-29 |
| DISTRAC(TM) TABLE (K900475) | Lossing Orthopedic, Inc. | 1990-05-24 |
| VAX-T PELVIC TRACTION BELT (K894435) | Vat-Tech, Inc. | 1989-08-03 |
| TRU TRAC TRACTION TABLE (K893448) | Tru-Trac | 1989-06-09 |
| SPINALATOR JS-1100 TRACTION UNIT (K893168) | The Spinalator Co. | 1989-05-26 |
| ULTRA TRACTION (K881603) | Component Equipment Mfg., Inc. | 1988-05-04 |
| GUS TRAC C-303 (K872780) | Gus Company, Inc. | 1987-10-06 |
| TEC VARI-TRAC II TRACTION UNIT (K862846) | Therapeutic Equipment Corp. | 1986-08-07 |
| TRU-TRAC 3-DIMENSIONAL CERVICAL TRACTION-TD-9000 (K862579) | Tru-Trac | 1986-08-06 |
| RICH-MAR SPINA-MOBILIZOR (K861832) | Rich-Mar Corp. | 1986-06-27 |
| POWERED TRACTION EQUIPMENT (K860227) | R. P. Hood, Inc. | 1986-02-06 |
| ESCOTEK EST TRAC 401 (K844385) | Nor-Am Patient Care Products, Inc. | 1985-05-01 |
| DONWAY SPLINT (K843522) | Australian Biomedical Corporation , Ltd. | 1985-02-07 |
| PROM NAID (K843581) | Lossing Orthopedic, Inc. | 1984-12-11 |
| TEC TRACTION MACHINE (K834405) | Akron Medical Corp. | 1984-01-13 |
| TRACTION 230 (K830088) | Tri W-G, Inc. | 1983-01-24 |
| INVERCHAIR (K821002) | Inverchair Marketing, Inc. | 1982-06-22 |
| CERVICAL TRACTION DIV., PNEUMATIC (K772154) | Jobst | 1977-11-30 |
| TABLE, TREATMENT & TRACTION, HI-LO (K770610) | Will Ross Co. | 1977-04-08 |
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Every clearance here is in the API, with alerts when new ones post.