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SuperNova$

07/07/18 10:15 AM

#145156 RE: DewmBoom #145154

DB, I don't have a sub so I can't search the board. I know ActiPatch is/was classified as a PEMF if I recall correctly, but I think I read where there was a new classification designation for ActiPatch established. Something like SWF, not sure. What was it and what does it stand for. I realize I could be off here, so thanks for any help.
$BIEL

markjohn62

07/07/18 10:19 AM

#145157 RE: DewmBoom #145154

I prefer not to wait 8-9 months to submit that 510k though.

Entry in Sept, picks for the challenge in Nov, 90 days for them to review, then file the expidited 510k (30 days?) I'd like to see it submitted ASAP, hopefully when the general clearance 510k is out of the way, but we have to do it the way the FDA recommends.