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This product uses traction to assist the human body's natural ability to change and develop under physical influence. "Go opt-in, multi-touch and multi-channel with your marketing. 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.  my page -  http://www.fashionmia.com/Tag/long-black-dress.html