Good news: Congratulations to JUMPER for obtaining the US FDA 510K certification approval for the first left chest continuous measurement electronic thermometer

Shenzhen JUMPER Company is a professional manufacturer specializing in the research and development, sales, and production of medical devices related to women and children. Its products include thermometers, blood pressure monitors, stimulators, fetal heart rate and monitoring, blood oxygen, and other products. The product has been sold to the Chinese, European, and American markets, and there is a strong desire for FDA 510K certification in the United States.

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 one trillion US dollars (compared to one trillion Chinese yuan), while there are 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.

In 2018, JUMPER once again chose Rui Enni Consulting as a trusted partner as the registration agent for FDA 510K certification in the United States. The wireless continuous body temperature patch of this customer is a relatively new application product in the market, and there are mainly the following difficulties:

1) The measurement site, aside from the traditional armpit, chose to measure the temperature of the left chest;

2) Measurement time, 24-hour continuous monitoring;

3) Transmission method, customer developed app using wireless BLUETOTH transmission technology

With professional guidance and document preparation from Ruini Consulting, we obtained the 510K certification approval from the US FDA in 2019. The K number is K182437. In cooperation, Rui Enni Consulting always provides customers with more services, and professionalism and service are the foundation of the consulting company's operation.