Replies to post #110079 on Bioelectronics Corp (BIEL)

[Zorax]

And you highlight boiler plate text that is in all FDA clearances.

Correct, I don't make stuff up and FDA rules and regulations and guidelines are not boilerplate.

is there any evidence that BIEL is NOT complying with the act, remember they have been selling an FDA cleared device for many years ahead of the OTC clearance for Actipatch.

Yes. No actipatch on US retail shelves. Means biel can't sell here. Thus biel isn't complying or trying to.

would they have cleared Actipatch if they knew they were not complying?

The device only reclassified to class II for the US FDA because beil changed the wording and reinvented itself product wise in anticipation of selling on US shelves. Selling online and in Canada does not address the only point in contention and that is biel has not been successful in putting product in front of US customers in the retail store space.

FDA did NOT APPROVE actipatch for sell in US, they only gave biel the new classifiaction that would make it easier for biel to do so. It's not and that's on biel, no one else.

Sadly, this may all go away when the SEC proceeds further into the lawsuit. whelan and family have clearly been sucking biel dry all this time. Classic bait and switch game.