Product Code: ITH FDA class 2 21 CFR 890.5900

Equipment, Traction, Powered

Physical Medicine

Powered traction equipment is an electrically or mechanically powered device used to apply sustained or intermittent longitudinal traction to the spine or extremities for decompression and pain relief in musculoskeletal conditions. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification. The product code is ITH, regulated under 21 CFR 890.5900, within the Physical Medicine medical specialty. This device is eligible for third party 510(k) review.

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FEI Numbers

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Basic Information

Product Code: ITH
Device Class: FDA class 2
Regulation Number: 890.5900
Medical Specialty: Physical Medicine
Review Panel: PM
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 71 510(k) clearances via K numbers.

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