Intuvie Holdings LLC

CLOSEOUT LETTER Intuvie Holdings LLC MARCS-CMS 629844 — July 16, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA Electronic Mail Product: Medical Devices Recipient: Recipient Name Frederick Lee Recipient Title Chief Executive Officer Intuvie Holdings LLC Zyno Medical LLC 177 Pine St Natick , MA 01760 United States Fred.Lee@intuvie.com Issuing Office: Office of Medical Devices and Radiological Health Operations Div. 1 East United States Secondary Issuing Offices United States Dear Mr. Lee: The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 629844, dated July 12, 2022). Based on our evaluation, it appears that you have addressed the violations 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/ CAPT Cesar A. Perez, PhD, USPHS Acting Deputy Director Office of Regulatory Programs Office of Product Evaluation and Quality Center for Devices and Radiological Health Content current as of: 07/21/2026 Regulated Product(s) Medical Devices