Date:   5/29/2016 4:50:21 PM ( 8 y ago)
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URL:   https://www.curezone.org/forums/fm.asp?i=2319898

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No risk found:

Our last FOIA ( freedom of information act ) inquiry to the FDA was responded to with a statement the following:

__________

Has anyone ever reported any injury or negative health issues from using any ParaZapper product?
Their Response: We could not find any information pertaining to this.

Has any Customer of Para Systems and Devices, LLC filed any complaint or claim with the FDA?
Their Response: We could not find any information pertaining to this.

Has any Customer of Para Systems and Devices, LLC ever complained of any injury from one of its products?
Their Response: We could not find any information pertaining to this.

_________ Note: the FDA keeps thorough and extensive records.


The FDA absolutely has not found any risk associated with ParaZapper or any other zapper that produces less than 12 volts output other than possibly triggering a pacemaker which is the fault of the pacemaker and is warned about.

>- Class III is the

Actually, you are not completely informed.

According to the FDA letter, the classification was made on the basis of 513-f ( It is intended to apply to low risk products that have been classified as class III because they were found not substantially equivalent (NSE) to any identifiable predicate device. )

In other words, because the product is different from other approved devices, they marked it as ( unknown or risky due to not having a standard developed ).

One reason for this is that while Beck users and many regular Clark zapper users were not able to penetrate deeply into internal organs, some ParaZapper customers had claims of success in this, making ParaZapper beyond other zappers and this was considered an unknown and therefore classified as possibly risky until further evaluated.

So the classification was not based on actual risk but instead on perceived possible risk.

BTW, this is valid only if a products is sold as a medical device, intended to treat or cure any disease, illness, or condition of the human body.



 

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