Nice Riccikeeper!
See this is what baffles me. The concept behind our "gizmos" is known worldwide. It (PEMF) is being USED worldwide. It IS a known and proven science. All BIEL has done was miniaturize it.
The technology is out there AND IT WORKS!! It IS safe! C'mon FDA, require labeling for restricting uses and get the dang thing out there for your citizens. You have spent long enough time prohibiting the people of the country you work for, from this side affect free alternative to pain relief, and I would say that you have punished this company enough for their previous marketing error of selling in U.S..
If previous study submission(s) were insufficient in FDA requirements, let's hope that lessons were learned and this "one" satisfies.