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tjshooker

10/10/12 2:26 PM

#26869 RE: Threepointer #26868

Agreed. They lumped BIEL in with Diapulse that makes the huge PEMF machines. And they make it sound as though BIEL wants classII for ALL SWD's. Which I'm quite certain is not exactly what they're asking for.

Of the comments on there now I suggest reading Mary Whelan's and Ivivi's.

http://www.regulations.gov/#!docketBrowser;dct=PS;rpp=25;po=0;D=FDA-2012-N-0378