International distributors are supplied with a Certificate to Foreign Government, complying with FDA requirements.
FTI is registered with the U.S. State Department Directorate of Defense Trade Controls as a manufacturer of defense articles and in full compliance with ITAR (International Traffic Arms Regulations).
Our medical cables are FDA listed Class 1 Medical devices. FDA Class 1 Product Codes are EQH and LXH listed.
Click here for a full technical file for our medical light guides.
Our LO-50 light source is 510K certified.
All electronic components are ETL approved to UL (Underwriter Laboratory) specification(s).
In addition, our light sources for Machine Vision applications are CE approved, including the 2001 power factor correction mandate, for our European customers.
Documentation, formal process control, and a system of checks and balances help maintain quality and fulfill QA mandates of the government.