Invacare Corporation

CLOSEOUT LETTER Invacare Corporation MARCS-CMS 617319 — August 21, 2023 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Medical Devices Recipient: Recipient Name Geoffrey P. Purtill Recipient Title President and CEO Invacare Corporation One Invacare Way Elyria , OH 44035 United States gpurtill@invacare.com Issuing Office: Center for Devices and Radiological Health United States Dear Mr. Geoffrey P. Purtill: The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter WL # 617319 dated November 18, 2021. 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 a subsequent inspection or through other means. Sincerely, /S/ Gina M. Brackett, Director of Compliance Office of Medical Devices & Radiological Health Division-1 East Office of Regulatory Affairs U.S. Food and Drug Administration CC: Jason Fiest (VP of Quality and Regulatory Affairs for North America) Email: jfiest@invacare.com Content current as of: 08/24/2023 Regulated Product(s) Medical Devices