Zynex Medical, Inc.

CLOSEOUT LETTER Zynex Medical, Inc. MARCS-CMS 423378 — December 18, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: UPS Overnight Reference #: DEN-14-08-WL Product: Medical Devices Recipient: Recipient Name Thomas Sandgaard Recipient Title Founder, Chairman and CEO Zynex Medical, Inc. 9555 Maroon Circle Englewood , CO 80112 United States Issuing Office: Office of Medical Device & Radiological Health Operations Division 3/West United States Dear Mr. Sandgaard: The Food and Drug Administration (FDA) has completed an evaluation of your corrective actions in response to our Warning Letter DEN-14-08-WL, dated June 27, 2014. Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections. This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during subsequent inspections or through other means. Sincerely, /S/ Kelly Sheppard Director, Compliance Branch Office of Medical Device & Radiological Health Operations Division 3/West Content current as of: 12/31/2019 Regulated Product(s) Medical Devices