Congratulations to Shenzhen ROUNDWHALE on their Prescription Electrical Stimulator project that passed 510K approval with zero defects

Shenzhen ROUNDWHALE is a newly established company specialising in the production of TENS, EMS, IF and other 

electrical stimulators.

       Because our general consultant has deep experience in the stimulator industry, the customer's company was 

established at the beginning of the company, the company's products of CE, FDA and domestic registration and 

system establishment of the project all packaged to our counselling.

       With our professionalism on electrical stimulators and our ability to understand the 510K regulations, we passed 

the FDA's approval within three months with zero defects after submitting the meticulously prepared 510K technical 

documents and obtained the approval of the K. The K number is K181688.

      This is the second case of our company to obtain 510K approval with zero defects since 2018.