Re: Nothing vague or misleading about this: ParaZapper Works! - video published 2003

>- mislead readers to think

Perhaps a better explanation of this as a clarification.

Basically, it was relayed to me that only if a product had an effect when used as a medical device could it be so classified.

Also, the risk classification was only applied because if used as a medical device it did have an effect. And since there was not any equivalent device in their database, the risks were not known, they had to classify it as being risky until they could evaluate it further.

In other words, if it was not effective then it was not a medical device and therefore could not be a class-3 medical device.

This information was from one of the lawyers that I consulted with who was a former FDA prosecutor. He was a wealth of information.
Tweet