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If the expected service is sufficient to justify listing for reimbursement, the guidance of CNEDi - MTS will also be based on the ASA in relation to a comparable product, considered to be the current gold standard, whether or not this gold standard is reimbursed. And if it does relate, hopefully it's not an ad for a competing product or service. 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.  Take a look at my web-site  http://www.wimhofmethod662.org/