Omnisense Systems Pte Ltd

CLOSEOUT LETTER Omnisense Systems Pte Ltd MARCS-CMS 613561 — July 20, 2023 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Medical Devices Recipient: Recipient Name Leonard Lim Omnisense Systems Pte Ltd 8 Penjuru Lane 609189 Singapore enquiries@omnisense-systems.com Issuing Office: Center for Devices and Radiological Health United States Dear Leonard Lim: The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS #613561, dated March 4, 2021). Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. 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 in the future. Sincerely yours, /S/ Courtney H. Lias, Ph.D. Director Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health CC: Andrew Southern Invisible Health Technologies 520 West 27th St.Suite 407 New York, NY 10001 andrew@invisiblehealthtechnologies.com Andrew Southern Invisible Health Technologies 3250 NE 1st Ave, Suite 305 Miami, FL 33137 andrew@invisiblehealthtechnologies.com Adam Lim Native Instinct LLC 3206 Canal Drive, Boynton Beach, FL 33435 adam@nativeinstinct.co Content current as of: 07/24/2023 Regulated Product(s) Medical Devices