Product code ITH— Physical Medicine
SPINA SYSTEM
- Classification name
- Equipment, Traction, Powered
- Device class
- Class 2
- Regulation
- 21 CFR 890.5900
- Advisory panel
- Physical Medicine
- Total cleared
- 71
- First cleared
- Most recent
Market context for product code ITH
FDA has cleared devices under product code ITH between 1977 and 2025, filed by 59 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2025
- 2024
- 2023
- 2015
- 2014
- 2012
- 2011
- 2010
- 2009
- 2008
- 2007
- 2006
- 2005
- 2004
- 2003
Top applicants under product code ITH
Recent clearances under product code ITH
- K243775 — True Non-Surgical Spinal Decompression System (DRX9000-SL)
- K243366 — DRX9000C-SL Cervical Spinal Decompression System
- K214037 — Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-Trac
- K222912 — c1Trac
- K151640 — ELTRAC 471
- K150695 — Modpod
- K131983 — ITRAC CERVICAL TRACTION SYSTEM
- K130249 — INTEGRITY SPINAL CARE SYSTEM 3.0
- K112074 — EVERYWAY TRACTION UNIT, MODEL EVER-TRAC ET-800
- K103248 — INTEGRITY SPINAL CARE SYSTEM
- K101889 — DECOMPRESSION OF CHOICE AND NEURO DECOMPRESSION DEVICE
- K091540 — MTD 4000
- K081247 — TM-400
- K072064 — GRAVILAX TRACTION SYSTEM
- K073132 — MODEL D DISC FORCE
- K073542 — CYCLETRAC CT-5000
- K071347 — VAX-D GENESIS G2 SYSTEM
- K063353 — CTBOX CERVICAL/LUMBAR TRACTION
- K060735 — DRX9000 TRUE SPINAL DECOMPRESSION SYSTEM
- K053223 — TRITON/TRU-TRAC/TX/TRITON DTS TRACTION
- K052453 — TRACTION SYSTEM, DIGIT-TRAC 930
- K053503 — VAX-D GENESIS SYSTEM (THERAPEUTIC TABLE)
- K051938 — TRITON/TRU-TRAC/TX TRACTION DEVICES
- K033231 — SPINA SYSTEM
- K051013 — SPINEMED S200B/S200C
- K042482 — BASS ANTALGIC-TRAK
- K043239 — HEALTHSTAR ELITE
- K031996 — EXTENTRAC ELITE
- K031862 — SPINERX-LDM
- K031227 — LORDEX POWER TRACTION EQUIPMENT
- K030060 — SPINEMED
- K022602 — DRX3000
- K023160 — DRX5000
- K010292 — DRX 2000
- K001712 — 3D ACTIVETRAC
- K002260 — SPINA SYSTEM
- K001361 — JILCO TRACTION-FLEXION CHAIR
- K001296 — SPINAL CORD AND IMMOBILIZATION TRACTION SYSTEM
- K001401 — AMT THERAPEUTIC TABLE, MODEL 748AMT
- K993919 — DYNATRON 900
- K991835 — HANG UPS POWER II
- K992733 — AKRON ATP9 TRACTION MACHINE
- K992545 — TM-300 TRACTION SYSTEM
- K991931 — CTD MARK I TRACTION DEVICE
- K981822 — DRS SYSTEM
- K951622 — VAX-D THERAPEUTIC TABLE
- K944699 — ATT-300
- K951228 — ASH-7000
- K940200 — EXCEL TX
- K940590 — MINTO SKIN TRACTION MOTOR
- K930691 — ACCUTRAC TRACTION UNIT
- K923103 — JT-1 POWERED TRACTION UNIT
- K900575 — ULTRA-TRAC
- K900475 — DISTRAC(TM) TABLE
- K894435 — VAX-T PELVIC TRACTION BELT
- K893448 — TRU TRAC TRACTION TABLE
- K893168 — SPINALATOR JS-1100 TRACTION UNIT
- K881603 — ULTRA TRACTION
- K872780 — GUS TRAC C-303
- K862846 — TEC VARI-TRAC II TRACTION UNIT
- K862579 — TRU-TRAC 3-DIMENSIONAL CERVICAL TRACTION-TD-9000
- K861832 — RICH-MAR SPINA-MOBILIZOR
- K860227 — POWERED TRACTION EQUIPMENT
- K844385 — ESCOTEK EST TRAC 401
- K843522 — DONWAY SPLINT
- K843581 — PROM NAID
- K834405 — TEC TRACTION MACHINE
- K830088 — TRACTION 230
- K821002 — INVERCHAIR
- K772154 — CERVICAL TRACTION DIV., PNEUMATIC
- K770610 — TABLE, TREATMENT & TRACTION, HI-LO
Data sourced from openFDA. This site is unofficial and independent of the FDA.