>- please give us some of the details, the quick-over explanation, as you see it, as to why the FDA has shut you down?
I will try within the constraints of limited time and space.
You will notice that other zappers have claimed to be qualified as Class II devices and in the past some have been approved as such in other countries such as Canada and the EU. The FDA has informed us that ParaZapper has been classified as a Class III device ( in the same group as a pacemaker ) due to its capabilities.
They require the following for a Class III device.
Registration of the company $$
Registration of the product $$
Registration and certification of the manufacturing facility $$
Proof the the product is safe ( according to FDA requirements ) $$$$$$$$$$ millions
Proof the the product works as described $$$$$$$$$$$ millions for each and ever use allowed.
There are many other requirements.
>- What is it, exactly, that they deem problematic with your zapper business?
Their written complaint is that we did not notify them in advance of marketing our product.
>- assumption that the FDA does not have a problem with you publicly disclosing their posistion.....perhaps this is a flawed assumption.....?