Bioelectronics Corp (BIEL)

[prussian4profit]

It seems my original post upset our special snowflake moderator. Poor Mr. " I know the company inside and out."

Here we go again.


"The entity that wants to sell the Shenzhen CICD device in the USA does NOT have to prove safety or efficacy in a 510(k) because that's not required in a 510(k)."


"A 510(k) requires demonstration of substantial equivalence to another legally U.S. marketed device. Substantial equivalence means that the new device is as safe and effective as the predicate. the information submitted to FDA demonstrates that the device is as safe and effective as the legally marketed device."

Are you serious?

One guess where that quote comes from. You claim not to lie, yet here we are. But, by all means keep up with these incredibly and increasingly ridiculous posts.

OMG.