FDA Product Code ITH: Equipment, Traction, Powered
Leading manufacturers include Excite Medical of Tampa Bay, LLC, Ito Co., Ltd. and Chattanooga Group.
71
Total
71
Cleared
133d
Avg days
1977
Since
Stable submission activity - 2 submissions in the last 2 years
Review times increasing: avg
227d
recently vs 130d historically
FDA 510(k) Cleared Equipment, Traction, Powered Devices (Product Code ITH)
71 devices
Cleared
Jul 18, 2025
True Non-Surgical Spinal Decompression System (DRX9000-SL)
Excite Medical of Tampa Bay, LLC
Physical Medicine
221d
Cleared
Jun 18, 2025
DRX9000C-SL Cervical Spinal Decompression System
Excite Medical of Tampa Bay, LLC
Physical Medicine
233d
Cleared
Feb 22, 2024
Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-Trac
Ergo-Flex Technologies, LLC
Physical Medicine
791d
Cleared
May 16, 2023
c1Trac
Zimmer Medizinsysteme GmbH
Physical Medicine
232d
Cleared
Oct 16, 2015
ELTRAC 471
Enraf-Nonius, B.V.
Physical Medicine
120d
Cleared
Aug 13, 2015
Modpod
Hollywog, LLC
Physical Medicine
148d
Cleared
Sep 10, 2014
ITRAC CERVICAL TRACTION SYSTEM
Pivotal Health Solutions
Physical Medicine
439d
Cleared
Feb 06, 2014
INTEGRITY SPINAL CARE SYSTEM 3.0
Integrity Life Sciences
Physical Medicine
370d
Cleared
Feb 01, 2012
EVERYWAY TRACTION UNIT, MODEL EVER-TRAC ET-800
Everyway Medical Instruments Co.,Ltd
Physical Medicine
196d
Cleared
Apr 05, 2011
INTEGRITY SPINAL CARE SYSTEM
Integra Life Sciences
Physical Medicine
153d
Cleared
Oct 08, 2009
MTD 4000
Mettler Electronics Corp.
Physical Medicine
135d
Cleared
Aug 25, 2008
TM-400
Ito Co., Ltd.
Physical Medicine
116d
Cleared
Apr 21, 2008
GRAVILAX TRACTION SYSTEM
Therapeutic Clinical Technologies, Inc.
Physical Medicine
269d
Cleared
Apr 03, 2008
MODEL D DISC FORCE
North American Medical Corp (Nam)
Physical Medicine
148d
Cleared
Feb 14, 2008
CYCLETRAC CT-5000
Pt Products, LLC
Physical Medicine
59d
Cleared
Oct 05, 2007
VAX-D GENESIS G2 SYSTEM
Vax-D Medical Technologies, LLC
Physical Medicine
144d
Cleared
Mar 14, 2007
CTBOX CERVICAL/LUMBAR TRACTION
Circular Traction Supply, Inc.
Physical Medicine
128d
Cleared
May 26, 2006
DRX9000 TRUE SPINAL DECOMPRESSION SYSTEM
Axiom Worldwide, Inc.
Physical Medicine
67d
Cleared
Feb 24, 2006
TRITON/TRU-TRAC/TX/TRITON DTS TRACTION
Chattanooga Group
Physical Medicine
99d
Cleared
Jan 13, 2006
TRACTION SYSTEM, DIGIT-TRAC 930
Ever Prosperous Instrument, Inc.
Physical Medicine
128d
Cleared
Dec 28, 2005
VAX-D GENESIS SYSTEM (THERAPEUTIC TABLE)
Vax-D Medical Technologies USA, L.C.
Physical Medicine
12d
Cleared
Sep 21, 2005
TRITON/TRU-TRAC/TX TRACTION DEVICES
Chattanooga Group
Physical Medicine
65d
Cleared
Apr 27, 2005
SPINEMED S200B/S200C
Cert Health Sciences, LLC
Physical Medicine
6d
Cleared
Mar 21, 2005
BASS ANTALGIC-TRAK
Traction Masters, LLC
Physical Medicine
189d
About Product Code ITH - Regulatory Context
510(k) Submission Activity
71 total 510(k) submissions under product code ITH since 1977, with 71 receiving FDA clearance (average review time: 133 days).
Submission volume has remained relatively stable over the observed period, with 2 submissions in the last 24 months.
FDA 510(k) Review Time - ITH Product Code
Recent submissions under ITH have taken an average of 227 days to reach a decision - up from 130 days historically. Manufacturers should account for longer review timelines in current project planning.
ITH devices are reviewed by the Physical Medicine panel. Browse all Physical Medicine devices →