LifeVac, LLC

CLOSEOUT LETTER LifeVac, LLC MARCS-CMS 713455 — March 04, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Medical Devices Ear, Nose & Throat Recipient: Recipient Name Mr. Arthur Lih Recipient Title CEO LifeVac, LLC 110 Lake Avenue South Ste 35 Nesconset , NY 11767-1071 United States alih@lifevac.net Issuing Office: Center for Devices and Radiological Health United States Secondary Issuing Offices United States March 4, 2026 Dear Mr. Lih: The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 713455, dated September 18, 2025). 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/ Srinivas Nandkumar, Ph.D. Director, Division of Dental and ENT Devices, Office of Health Technology 1, Ophthalmic, Anesthesia, Respiratory, ENT & Dental Devices Center for Devices and Radiological Health Content current as of: 03/04/2026 Regulated Product(s) Medical Devices Ear, Nose & Throat