Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-Trac— 510(k) K214037

Name: FDA 510(k) clearance K214037
Creator: U.S. Food and Drug Administration
Published: 2024-02-22

Substantially Equivalent

Ergo-Flex Technologies, LLC

FDA 510(k) clearance K214037 for Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-Trac, Substantially Equivalent on 2024-02-22. Applicant: Ergo-Flex Technologies, LLC. Device class: 2.

Clearance details

Applicant: Ergo-Flex Technologies, LLC
Product code: Code ITH
Device class: Class 2
Regulation: 21 CFR 890.5900
Advisory panel: Physical Medicine
Date received: 2021-12-23
Decision date: 2024-02-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Conroe, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code ITH

view all

K243775 — True Non-Surgical Spinal Decompression System (DRX9000-SL)2025-07-18
K243366 — DRX9000C-SL Cervical Spinal Decompression System2025-06-18
K222912 — c1Trac2023-05-16
K151640 — ELTRAC 4712015-10-16
K150695 — Modpod2015-08-13

Data sourced from openFDA. This site is unofficial and independent of the FDA.