Home / 510(k) Clearances / K053223

510(k) K053223

TRITON/TRU-TRAC/TX/TRITON DTS TRACTION by Chattanooga Group — Product Code ITH

K053223 is an FDA 510(k) premarket notification submitted by Chattanooga Group for the device "TRITON/TRU-TRAC/TX/TRITON DTS TRACTION". The FDA issued a decision of Substantially Equivalent on February 24, 2006. The device falls under product code ITH (Equipment, Traction, Powered), a Class II device regulated under 21 CFR 890.5900. Chattanooga Group has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 2006
Date Received
November 17, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Equipment, Traction, Powered
Device Class
Class II
Regulation Number
890.5900
Review Panel
PM
Submission Type

Other clearances by Chattanooga Group

  • K090632 — COMPEX REHAB (June 1, 2009)
  • K083433 — INTELECT SWD 100, MODEL 1600; SENIOR SOLUTIONS SHORTWAVE DIATHERMY, MODEL 1601 (March 18, 2009)
  • K083140 — COMPEX SPORT PLUS (February 9, 2009)
  • K070425 — VITALSTIM EXPERIA (June 11, 2007)
  • K051938 — TRITON/TRU-TRAC/TX TRACTION DEVICES (September 21, 2005)
  • K040662 — VECTRA GENISYS (MODULE & TRANSPORTABLE) AND INTELECT XT (MODULE & TRANSPORTABLE) (September 8, 2004)
  • K040285 — VECTRA TRANSPORTABLE COMBO AND STIM (SPECIALTY LINE DEALERS); INTELECT TRANSPORT (April 12, 2004)
  • K031077 — VECTRA EPR SYSTEM AND INTELECT EPR SYSTEM (December 11, 2003)
  • K031116 — VECTRA (INTELECT) EPR ULTRASOUND (December 3, 2003)
  • K023347 — VITAL STIM (December 6, 2002)

Other clearances for product code ITH

  • K243775 — True Non-Surgical Spinal Decompression System (DRX9000-SL) (July 18, 2025)
  • K243366 — DRX9000C-SL Cervical Spinal Decompression System (June 18, 2025)
  • K214037 — Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-Trac (February 22, 2024)
  • K222912 — c1Trac (May 16, 2023)
  • K151640 — ELTRAC 471 (October 16, 2015)
  • K150695 — Modpod (August 13, 2015)
  • K131983 — ITRAC CERVICAL TRACTION SYSTEM (September 10, 2014)
  • K130249 — INTEGRITY SPINAL CARE SYSTEM 3.0 (February 6, 2014)
  • K112074 — EVERYWAY TRACTION UNIT, MODEL EVER-TRAC ET-800 (February 1, 2012)
  • K103248 — INTEGRITY SPINAL CARE SYSTEM (April 5, 2011)

FDA data resources