How do we know these are perfectly functioning devices? The average person wouldn't read studies and documentation or ascertain the quality - I barely can and check HN comments for many medical studies :) FDA approval is a very strong signal at least.
I'd rather avoid the supplements situation where manufacturers can essentially claim almost anything and most of the population isn't aware that it's a free-for-all. Manufacturers can still claim some function but at least there's currently a disclaimer that makes average people question some claims.
I don't really love the mix of deregulation and healthcare (even adjecent, see supplements).