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.