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510(k) K063353

CTBOX CERVICAL/LUMBAR TRACTION by Circular Traction Supply, Inc. — Product Code ITH

K063353 is an FDA 510(k) premarket notification submitted by Circular Traction Supply, Inc. for the device "CTBOX CERVICAL/LUMBAR TRACTION". The FDA issued a decision of Substantially Equivalent on March 14, 2007. The device falls under product code ITH (Equipment, Traction, Powered), a Class II device regulated under 21 CFR 890.5900.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 2007
Date Received
November 6, 2006
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

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  • 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