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Panels › Physical Medicine › Product code ITH · Class 2

Equipment, Traction, Powered

Regulation 890.5900

0510(k)s in 12 months (71 all time)
0recalls in 12 months (5 all time)
4recalls that name a 510(k)
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Top companies in ITH

Company510(k)sRecalls
Advanced Back Technologies12
North American Medical Corp (Nam)30
Pivotal Health Solutions21
Axiom Usa., Inc.20
Axiom Worldwide, Inc.20
Cert Health Sciences, LLC20
Chattanooga Group20
Ever Prosperous Instrument, Inc.20
Excite Medical of Tampa Bay, LLC20
Ito Co., Ltd.20
Decided510(k)Device and applicantCode
Jul 18, 2025K243775True Non-Surgical Spinal Decompression System (DRX9000-SL)
Excite Medical of Tampa Bay, LLC
ITH
Jun 18, 2025K243366DRX9000C-SL Cervical Spinal Decompression System
Excite Medical of Tampa Bay, LLC
ITH
Feb 22, 2024K214037Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-Trac
Ergo-Flex Technologies, LLC
ITH
May 16, 2023K222912c1Trac
Zimmer Medizinsysteme GmbH, DE
ITH
Oct 16, 2015K151640ELTRAC 471
Enraf-Nonius, B.V., NL
ITH
Aug 13, 2015K150695Modpod
Hollywog, LLC
ITH
Sep 10, 2014K131983ITRAC CERVICAL TRACTION SYSTEM
Pivotal Health Solutions
ITH
Feb 6, 2014K130249INTEGRITY SPINAL CARE SYSTEM 3.0
Integrity Life Sciences
ITH
Feb 1, 2012K112074EVERYWAY TRACTION UNIT, MODEL EVER-TRAC ET-800
Everyway Medical Instruments Co.,Ltd
ITH
Apr 5, 2011K103248INTEGRITY SPINAL CARE SYSTEM
Integra Life Sciences
ITH
Aug 27, 2010K101889DECOMPRESSION OF CHOICE AND NEURO DECOMPRESSION DEVICE
Pivotal Health Solutions
ITH
Oct 8, 2009K091540MTD 4000
Mettler Electronics Corp.
ITH
Aug 25, 2008K081247TM-400
Ito Co., Ltd.
ITH
Apr 21, 2008K072064GRAVILAX TRACTION SYSTEM
Therapeutic Clinical Technologies, Inc.
ITH
Apr 3, 2008K073132MODEL D DISC FORCE
North American Medical Corp (Nam)
ITH
Feb 14, 2008K073542CYCLETRAC CT-5000
Pt Products, LLC
ITH
Oct 5, 2007K071347VAX-D GENESIS G2 SYSTEM
Vax-D Medical Technologies, LLC
ITH
Mar 14, 2007K063353CTBOX CERVICAL/LUMBAR TRACTION
Circular Traction Supply, Inc.
ITH
May 26, 2006K060735DRX9000 TRUE SPINAL DECOMPRESSION SYSTEM
Axiom Worldwide, Inc.
ITH
Feb 24, 2006K053223TRITON/TRU-TRAC/TX/TRITON DTS TRACTION
Chattanooga Group
ITH
Jan 13, 2006K052453TRACTION SYSTEM, DIGIT-TRAC 930
Ever Prosperous Instrument, Inc., TW
ITH
Dec 28, 2005K053503VAX-D GENESIS SYSTEM (THERAPEUTIC TABLE)
Vax-D Medical Technologies USA, L.C.
ITH
Sep 21, 2005K051938TRITON/TRU-TRAC/TX TRACTION DEVICES
Chattanooga Group
ITH
Sep 9, 2005K033231SPINA SYSTEM
North American Medical Corp (Nam)
ITH
Apr 27, 2005K051013SPINEMED S200B/S200C
Cert Health Sciences, LLC
ITH
Mar 21, 2005K042482BASS ANTALGIC-TRAK
Traction Masters, LLC
ITH
Dec 22, 2004K043239HEALTHSTAR ELITE
Hill Laboratories Co.
ITH
Jul 23, 2004K031996EXTENTRAC ELITE
Advanced Back Technologies
ITH
Oct 31, 2003K031862SPINERX-LDM
Spinerx Technology
ITH
Jul 17, 2003K031227LORDEX POWER TRACTION EQUIPMENT
Ever Prosperous Instrument, Inc.
ITH
Feb 5, 2003K030060SPINEMED
Cert Health Sciences, LLC
ITH
Jan 23, 2003K022602DRX3000
Axiom Usa., Inc.
ITH
Dec 20, 2002K023160DRX5000
Axiom Usa., Inc.
ITH
May 1, 2001K010292DRX 2000
Axiom Worldwide, Inc.
ITH
Aug 31, 2000K0017123D ACTIVETRAC
The Saunders Group
ITH
Aug 25, 2000K002260SPINA SYSTEM
North American Medical Corporation (Nam)
ITH
Jul 19, 2000K001361JILCO TRACTION-FLEXION CHAIR
Jilco Enterprises
ITH
Jul 17, 2000K001296SPINAL CORD AND IMMOBILIZATION TRACTION SYSTEM
Cavendish Scott, Inc.
ITH
Jul 12, 2000K001401AMT THERAPEUTIC TABLE, MODEL 748AMT
Amt Mfg., Inc., CA
ITH
Jan 3, 2000K993919DYNATRON 900
Dynatronics Corp.
ITH
Dec 20, 1999K991835HANG UPS POWER II
Stl Intl., Inc.
ITH
Nov 10, 1999K992733AKRON ATP9 TRACTION MACHINE
Huntleigh Technology, Inc.
ITH
Sep 1, 1999K992545TM-300 TRACTION SYSTEM
Ito Co., Ltd.
ITH
Aug 12, 1999K991931CTD MARK I TRACTION DEVICE
Therasys, Inc.
ITH
Jun 24, 1998K981822DRS SYSTEM
Professional Distribution Systems, Inc.
ITH
Jul 2, 1996K951622VAX-D THERAPEUTIC TABLE
Vat-Tech, Inc.
ITH
May 26, 1995K944699ATT-300
Health Care Mfg., Inc.
ITH
May 17, 1995K951228ASH-7000
U.S. Table, Inc.
ITH
Jun 7, 1994K940200EXCEL TX
Excel Tech. , Ltd., CA
ITH
Apr 15, 1994K940590MINTO SKIN TRACTION MOTOR
Minto Research & Development, Inc.
ITH

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