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This product uses traction to assist the human body's natural ability to change and develop under physical influence. If I were to ask you, "Who is the buyer of your medical devices. The question pertains to approval in Europe, Australia, Japan, Canada and how that relates to a US approval, and secondly, what type of 510(k) to prepare in the US.  Feel free to surf to my blog post -  http://Www.Ycc.asia/