>- existance of regulatory requirements for electronic things like class-of-product, Coffee-Enema approval, UL approval, yada yada yada on and on regulatory things like that.
Yes, I have dealt with many regulations over the years including a lot of Mil-Spec.
>- I am wondering if there is something specific about your circuit/design that puts it into this so-called class III rating
I do not know if it is specifically circuit design, perceived effectiveness, actual effectiveness, or whatever. The one thing that is completely bothersome to me is their negligent dis-consideration of the rights of the public. I agree that the FDA was provided a mandate by congress to insure that the public gets reliable health care equipment and products, but they are reaching beyond their bounds when they deny the public. As for why the raid, I think that what it boiled down to is that some universities and hospitals were seeing some serious positive results from a couple of our better products and were asking questions.
>- he sees the entire zapper market such that there is a lot of room for a lot of other people besides himself
I believe that this is the attitude of most if not all of the zapper sellers. There are and have been over 50 zapper sellers on the internet at any time. Additionally, there are many other local sellers.
>- impression that Don would continue to market/sell his zappers even in the face of FDA pressure
Michael Forrest did this ... just got out of jail.
>- like making an actual raid on his home with guns drawn kind of stuff
This is what happened to us (minus the guns drawn). They were ready for this possibility. Their parade took up the whole block and they occupied the entire house for almost the entire day.