Congratulations to Shenzhen ROUNDWHALE Company on the zero defect prescription electrical stimulator project, which is difficult to approve with 510K approval

Shenzhen ROUNDWHALE Company is a newly established enterprise specializing in the production of electrical stimulators such as TENS, EMS, IF, etc.
    
Due to our general consultant's extensive experience in the stimulator industry, the client's company packaged all the CE, FDA, domestic registration, and system establishment projects for the company's products and entrusted them to our company for guidance at the beginning of its establishment.

With our expertise in electrical stimulators and our ability to understand the 510K regulations, we carefully drafted the 510K technical documents and submitted them. Within three months, we passed the FDA approval with zero defects and obtained approval. The K number is K181688



This is the second case since 2018 where our company has received 510K approval for zero defects.