Lifeline Biotechnologies Inc (LLBO)

[KMGunter]

The fact that there posting on there website, about the upcoming 510(k) submission to the FDA, to commercialize the iTBra is a huge deal, and tells me they are still making good.

This is a non evasive, and minimal risk product, which falls under the class 1 with the FDA. Sometimes they are exempt from the 510(k), but need to be manufactured under a quality assurance program.

Class 1
-Suitable for intended use.

-Manufactured under quality assurance program.

-Adequate packaging and labeling.

-Registration of the manufacturing site/establishment.

-Device listing.

-Good manufacturing process.