Wickimed Medical Equipment Manufacturing Co., Ltd.

CLOSEOUT LETTER Wickimed Medical Equipment Manufacturing Co., Ltd. MARCS-CMS 623042 — May 23, 2022 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Medical Devices Recipient: Recipient Name Mr. Mac Lai Recipient Title CEO Wickimed Medical Equipment Manufacturing Co., Ltd. XingWang Street, LiLin Town ZhongKai Hi-Tech Zone Huizhou Shi Guangdong Sheng , 516003 China mac_lai@wickimed.com Issuing Office: Center for Devices and Radiological Health United States Dear Mr. Lai: The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CMS # 623042, dated January 7, 2022. 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 nor 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/ Cynthia Long, MD, FACS Acting Division Director Division of General Surgery Devices Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health CC: David Lennarz Registrar Corp144 Research Drive Hampton, VA 2366 Content current as of: 06/02/2022 Regulated Product(s) Medical Devices