Bioelectronics Corp (BIEL)

[Simpsonly]

I just did confirm for you that there has been a change by the FDA in the past 4 days!
The company has no obligation whatsoever to issue any PR with respect to the FDA getting the house in order. The information is in the public domain, you have the information. The company is maintaining a very professional stance with respect to the FDA process.

Please read my post 76130 again - here it is for your convenience. Be sure to check into the links provided to see with great clarity exactly what FDA has done to expedite the substantially equivalent - predicate device, so >140Million Americans with chronic pain can be helped as soon as possible.

iHUB post 76130:
"I love this kind of denial - FDA loves BIEL so much, having expend many thousands of man-hours and many millions of dollars on its SWT initiative, that they upgraded their 2002 ActiBand classification.....when was that you ask? Why it was just a few days ago April 25, 2016!

Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat

Translation:
(In the device categories of) Diathermy, Shortwave, -------For Use Other Than Applying Therapeutic Deep Heat

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=4715

Then, read this one from August 2015 . . .
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=890.5290

Ooooops.

>140Million Americans suffering from chronic pain and taking drugs, every day! Who in their right mind could ever think, in negative terms, about not helping those folks in every way possible?"