Hand Biomechanics Lab, Inc.

CLOSEOUT LETTER Hand Biomechanics Lab, Inc. MARCS-CMS 534495 — September 07, 2022 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA Electronic Mail Product: Medical Devices Recipient: Recipient Name Dr. John M. Agee, M.D. Recipient Title President Hand Biomechanics Lab, Inc. 77 Scripps Drive Sacramento , CA 95825 United States kasutton@handbiolab.com ddequine@handbiolab.com Issuing Office: Los Angeles District Office United States Dear Dr. Agee, The Food and Drug Administration has completed an evaluation of your corrective actions in response to a Warning Letter dated 11/16/2017. 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/ Jessica Mu Compliance Branch Director Office of Medical Device and Radiological Health Operations Division 3/West Content current as of: 09/09/2022 Regulated Product(s) Medical Devices