Good news - Congratulations to Dongguan Xingzhou Electronic Technology Co., Ltd. for winning the infrared thermometer 510 (K) number

The thermometer is one of our company's very mature products. The application process was very smooth, taking over 3 months from submitting the materials to FDA approval. On July 22, 2021, we received a written notification with three non conformities. One of the non conformities was a manual error in the test data in the third-party test report. Regarding this non conformity, our company quickly contacted Xingzhou Electronics and requested them to conduct a retest according to FDA requirements. The customer cooperated quickly and the test report was issued within three working days. Another error is the appearance of a fever warning on the color box. The main reason for this error is that the inspection of the color box information was not done properly, and the rectification plan was changed to a high temperature warning. The third issue is the cleaning, disinfection, and poisoning methods. The auditor requires that cleaning, disinfection, and poisoning be combined together, and there are special requirements for the tools used for cleaning, disinfection, and poisoning (previously applied for 510k, FDA requires separate cleaning, disinfection, and poisoning), and it is clear whether they are used by a single patient or multiple patients. As changes in cleaning, disinfection, and poisoning methods may involve revalidation, in order to avoid revalidation, we carefully revised the wording of the cleaning, disinfection, and poisoning methods and systematically explained why the changes before and after did not affect the previous validation. In just 4 days (July 27, 2021), we completed the rectification and submitted it to the FDA. After receiving the email, the FDA had a communication regarding the use of a single patient and multiple patients. Afterwards, the FDA did not raise any other questions until September 4th when we received the FDA's approval document for the 510 (K) thermometer. The 510 (K) application has been fully recognized by the client.