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  5. Zynex Medical, Inc. - 423378 - 12/18/2018
  1. Warning Letters

CLOSEOUT LETTER

Zynex Medical, Inc. MARCS-CMS 423378 —

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

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