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Simpsonly

02/19/16 6:57 PM

#72385 RE: Vitamix8173 #72381

shoot me a pm with email

RVC

02/19/16 7:55 PM

#72391 RE: Vitamix8173 #72381

Totally-False-CEO-->"No reason should not have clearance by year end"
RE: Since the law firm they hired to submit and handle their 510k took over the proceedings, we have heard "not a peep" of misinformation regarding anything positive or negative.

The CEO stated in a nationally aired "paid for" event: "no reason we should not have clearance before end of the year..."
For the record that was in 2015, thus there must be a reason the FDA has as of Feb-19-2016 NOT GRANTED clearance.

Maybe the FDA knew the company is under SEC investigations?

NoPinkScams

02/20/16 8:47 PM

#72428 RE: Vitamix8173 #72381

The October recategorization put PEMF in exactly the same spot it was previously, which is available via prescription. Long silence wasnt good the last time BIEL applied for clearance, moslty because the silence was driven by the CEO hiding the fact their applications had been flat out denied. Wouldn't surprise me one bit if history is repeating itself.