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1. FDA 510k Clearance
Migun Medical Instrument Co. Ltd. has recently received 510(k) premarket notification clearance as medical device class II from the Food and Drug Administration for the HY-5000 Thermal Massage System. For the past two and a half years, Migun U.S.A. has tried really hard to let FDA understand the quality and effects of Migun products as well as the oriental medicine that is embedded into Migun. Finally, FDA admitted that Migun HY-5000(7000) is a medical device class II. Usually, for a foreign based company, U.S. FDA approval is very rare.
The general population in United States is very knowledgeable and careful with medical products. For a long time, they've been looking for the best as far as health care is concerned no matter how much it costs. In this reason, the FDA in United States has the toughest standard in the world, and its approval is very well recognized in the world.
Also, HY-5000 has received OTC(Over the Counter) clearance, which means that a customer can purchase our products without getting a prescription from their doctors That is because the FDA believes that HY-5000 is safe enough for anyone. Now Migun has a clearance from the world's top medical standard. The clearance that Migun received is identical class with an incubator, an X-ray machine, an endoscope, and a radiotherapy machine, etc.
2. ETL certification
To be able to make a submission to the FDA, we needed to finish testing our products as a medical device class II. Unlike UL, ETL SEMKO's standards for medical products are recognized in other countries such as Canada and Europe. The standard that Migun HY-5000 is tested to (60601-2-38, 60601-1) indicates that the product meets the safety regulatory for Medical device class II. That is the same class as incubator, the machines for physical surgery, laser surgery machine, or gamma ray machine.
3. JVSR and clinical researches
J.V.S.R (Journal of Vertebral Subluxation Research) is a 'Peer-Reviewed Scientific Journal devoted to subluxation based chiropractic research.' Dr. So at University of California, Irvine has been has been performing extensive research study for the past three years at the University of California, Irvine on clinical effects for past two years. Some of the study results are published on the J.V.S.R. As a result, the article and Migun product have brought attention to many chiropractors throughout the nation. Dr. So is currently preparing to complete more clinical tests within the next few years. J.V.S.R. Publication means more than a study release. It took about a year for the editors to review the article over and over. They only put articles that are trustworthy and beneficial to human's spinal health. Also, University of California, Irvine does not allow its medical staff to study just any products. UCI Medical Board Committee saw Migun's product qualifications before allowing Dr. So to do the research.
4. ACA endorsement
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