Home / 510(k) Clearances / K060735

510(k) K060735

DRX9000 TRUE SPINAL DECOMPRESSION SYSTEM by Axiom Worldwide, Inc. — Product Code ITH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 2006
Date Received
March 20, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

Other clearances by Axiom Worldwide, Inc.

  • K051135 — AXIOM NVP8500 (August 11, 2005)
  • K050687 — AXIOM EPS8000 (July 28, 2005)
  • K010292 — DRX 2000 (May 1, 2001)

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)