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510(k) K214037

Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-Trac by Ergo-Flex Technologies, LLC — Product Code ITH

K214037 is an FDA 510(k) premarket notification submitted by Ergo-Flex Technologies, LLC for the device "Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-Trac". The FDA issued a decision of Substantially Equivalent on February 22, 2024. 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
February 22, 2024
Date Received
December 23, 2021
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 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)
  • 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)

FDA data resources