Cleared Traditional

Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-Trac

K214037 · Ergo-Flex Technologies, LLC · Physical Medicine

Feb 2024

Decision

791d

Days

Class 2

Risk

About This 510(k) Submission

K214037 is an FDA 510(k) clearance for the Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-Trac, a Equipment, Traction, Powered (Class II — Special Controls, product code ITH), submitted by Ergo-Flex Technologies, LLC (Conroe, US). The FDA issued a Cleared decision on February 22, 2024, 791 days after receiving the submission on December 23, 2021. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5900.

Submission Details

510(k) Number	K214037 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 23, 2021
Decision Date	February 22, 2024
Days to Decision	791 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Summary PDF