返回Shenzhen JUMPER is a professional manufacturer specialising in the research, development, sales and production
of medical devices for women and children, including thermometers, sphygmomanometers, stimulators, foetal heart
and fetal monitoring, blood oxygen and other products. The products have been sold to China, Europe and the United
States market, for the United States FDA 510K certification has a strong hope.
The United States as a global consumer country, the use of medical devices is also the world's . According to the
statistics of relevant organisations, the medical device market in the United States in 2017 was one trillion U.S. dollars
(China's medical device market is one trillion yuan), while the U.S. local medical device production and operation of
less than five hundred companies. So the United States relies heavily on imports of medical devices. China serves as
the world's factory base, so this is a very good opportunity for medical device manufacturers.
During 2018, JUMPER once again chose Reanny Consulting as a trusted partner as a registered agent for the US FDA
510K certification. This time, the customer's wireless continuous body temperature sticker is a relatively new application
product in the market, the main difficulties are as follows:
(1) Measurement site, leaving aside the traditional armpit chose to measure the temperature of the left chest;
(2) Measuring time, 24 hours continuous monitoring;
(3) Transmission mode, the customer develops its own APP, using wireless BLUETOOTH transmission technology.
After professional counselling and document preparation by Reanny Consulting, the 510K certification was approved
by the US FDA in 2019. The K number is K182437. In the cooperation, Reanny Consulting can always provide more
services to the customers, professionalism and service are the basis of the consulting company's business.
