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510(k) K243366

DRX9000C-SL Cervical Spinal Decompression System by Excite Medical of Tampa Bay, LLC — Product Code ITH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 2025
Date Received
October 28, 2024
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 Excite Medical of Tampa Bay, LLC

  • K243775 — True Non-Surgical Spinal Decompression System (DRX9000-SL) (July 18, 2025)

Other clearances for product code ITH

  • K243775 — True Non-Surgical Spinal Decompression System (DRX9000-SL) (July 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)
  • K101889 — DECOMPRESSION OF CHOICE AND NEURO DECOMPRESSION DEVICE (August 27, 2010)