Wello, Inc.

CLOSEOUT LETTER Wello, Inc. MARCS-CMS 664806 — October 22, 2024 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Medical Devices Recipient: Recipient Name Mr. Alan C. Heller Recipient Title President/CEO Wello, Inc. 15960 Midway Road Addison , TX 75001-4280 United States Issuing Office: Center for Devices and Radiological Health United States Secondary Issuing Offices United States Dear Mr. Heller: The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 664806, dated November 8, 2023). 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/ RDML Sean Boyd Director Office of Regulatory Programs Office of Product Evaluation and Quality Content current as of: 10/28/2024 Regulated Product(s) Medical Devices