SHENCHEN ROUNDWHALE is a newly established start-up company that mainly produces Class II electrical stimulators.
For new businesses, time equals money equals opportunity. So customers are very eager for early certification. Based on respect and support for entrepreneurs, our general consultant personally took charge of this project -510K registration.
After a month of organizing and preparing the submitted materials, it was submitted to the FDA in early March. Based on our expertise in stimulators and 510K, this case passed FDA review with zero defects and received approval letter in May.
During this period, the FDA sent an email highly praising our company's professionalism.
After obtaining the certificate, the customer promptly receives the company's [sensitive word] US orders, taking the [sensitive word] step towards enterprise sales.
Therefore, the customer expressed high appreciation and gratitude to our company. At the same time, both parties further signed a cooperation agreement for the CE and FDA projects.
