Congratulations to ROUNDWHALE for obtaining the 510K approval letter in 3 months with zero defects.

SHENZHEN ROUNDWHALE is a newly opened start-up company that manufactures Class II electrical stimulators.

For a new business, time equals money equals opportunity. Therefore, the client is very eager to obtain the licence 

as soon as possible. Based on the respect and support for entrepreneurs, our General Counsel personally took 

charge of this project - 510K registration.

After a month of submission and preparation, we submitted to FDA at the beginning of March, based on our 

professionalism on stimulators and 510K, this case passed FDA's audit with zero defects and got the approval letter 

in May.

During this period, FDA sent an email to highly appreciate our professionalism.

After obtaining the certificate, the customer got the U.S. order in time, and took the step of enterprise sales.

Here, the customer expressed high appreciation and thanks to our company. At the same time, the two sides further 

signed a CE and FDA project cooperation agreement.