Good news: Congratulations to ALICN for obtaining US FDA certification 510K approval

FDA certification
Shenzhen Alicn is a professional manufacturer specializing in the research and development, sales, and production of active medical devices, including thermometers, blood pressure monitors, stimulators, laryngoscopes, and other products. The product has been sold to the Chinese and European markets, and is actively developing the US market.

As a global consumer of sensitive words, the United States also has a high usage of medical devices. According to statistics from relevant institutions, the medical device market in the United States in 2017 was $100 billion (China's medical device market was $100 billion), while there were less than 500 domestic medical device manufacturers and operators in the United States. So the medical equipment in the United States heavily relies on imports. As a factory base for sensitive words in the world, China presents a great opportunity for medical device manufacturers.

Alicn prepared for the 510K registration of infrared thermometers and wireless printed arm blood pressure monitors in 2018. For the registration of wireless printed arm blood pressure monitors, both wireless and printing are significant challenges. After internal expert consultation, Ruini has made a detailed plan for wireless security, wireless coexistence, and security assessment.

Successfully obtained FDA certification 510K approval in November 2018 and January 2019, with K numbers K180207 and K180435. After obtaining the K number, based on the customer's request for help, our company also assisted the customer in completing the product registration and listing work free of charge.