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This product uses traction to assist the human body's natural ability to change and develop under physical influence. And because there is much to share, this article is broken into three parts that are based on the three ideas Malaspina and Scearce impart. 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.  Here is my homepage;  http://Scholar.Harvard.edu/sensemakingscholar/home