Recently, SUNGO coached an enterprise in Ningbo on the FDA 510K project for manual wheelchairs and the range include preparation of technical documentation and product testing services. The project took only 2 months from submission to approval and passed the FDA audit, now the product can be sold legally and freely in the U.S. market!
It is worth mentioning that the full set of tests of the company is carried out by SUNGO lab, which fully meets the requirements of the FDA and covers all points and areas of FDA concern.
Combined with the strength and experience of the SUNGO consulting team, the project was moving forward smoothly. No supplement was required in the whole process, and the approval was obtained within 60 days.
The speedy passing of the FDA's strict evaluation this time could not have been achieved without the close cooperation between SUNGO and the company. At the same time, it undoubtedly proved the reliable strength of both parties in their respective fields.
SUNGO focuses on the technology platform of inspection and testing services. After more than two years of development, we have built two testing and experimental sites, Shanghai laboratory and Hefei laboratory, and the laboratories have been accredited by the U.S. IAS.
SUNGO can conduct the following tests for customers.
I. performance testing of epidemic prevention materials such as surgical gowns, isolation gowns, medical gloves, medical masks, etc.
II. Performance testing of rehabilitation medical devices such as wheelchairs, mobility scooters, crutches, walkers, etc.
III. Packaging verification and simulated transportation and other general testing of packaging for sterile medical device products.
The test reports issued by the laboratory have been recognized by the authorities of the major international markets for medical devices in the world, such as the United States, the European Union and the United Kingdom.
SUNGO laboratories will continuously insist on the quality policy of "fairness and integrity, accuracy and efficiency, scientific methodology, standardized services " to provide customers with professional, efficient and satisfying technical services!