[chris_wot]

So why not test on the disabled and able-bodied alike? Make no health claims and sell to everyone as “excercise equipment”.

This seems to be a case where regulation is slowing innovation. And I don’t say that very often...

[nrclark]

It could be a money thing. If the product is a "medical device", that means an extra 1000% markup. Look at hearing aids as a perfect example of this. And yes, it probably does slow down the pace of innovation significantly.