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Furthermore, many companies simply don't have the money to make all of the changes and meet all the other demands asked of them in order to bring their product up to meet FDA standards. The human body and physiology in general are fairly well understood in terms of their basic mechanics. 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.wimhofmethod662.org/