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FDA Clearance, Patents & Trademarks

In 1997 the Food & Drug Administration (FDA) reaffirmed its previous and uninterrupted clearance for Finally Free to be marketed in the USA, in the wake of internal rule changes the FDA had instituted. If a company had a product being sold in the U.S. prior to the date of these changes and there were never any safety concerns or reported problems with the product, the product would be automatically "grandfathered" into the system without the company having to submit a new application. Nevertheless, we did resubmit a new application for Finally Free so that we could make a stronger statement about our product's compliance, knowing that no one else could make the claims we had. To see the FDA clearance letter, click here.

Finally Free is an exceptionally safe product for home use. Despite the power of its technology, you never have to worry about burns or electrocution. Click here to see the summary page from the clearance for classifying Finally Free as a Class I medical device. According to Wikipedia, such devices "present minimal potential for harm to the user . . . . These devices are subject to 'general controls' such as 'manufacturer registration with the FDA, good manufacturing techniques, proper branding and labeling, notification of the FDA before marketing the device, and general reporting procedures'".

As a patented technology, Finally Free cannot be copied or duplicated by any other manufacturer. Two legal letters describing the assignation of the patent can be found here and here, and the patent assignation itself is here. The patent application can be seen here. Finally Free is also trademarked, and the confirmation of the trademark registration can be found here.

 




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