Earlier quoted context omitted.
It turns out even if a company markets its products with big bold "not for diagnostic/medical use", and its customers use the products for diagnostic or medical use, the company can still be on the hook. It depends on a number of things, not least of which is the company's knowledge of the actual use of their devices.
That doesn't seem fair. What's a company supposed to do in that situation? Just close up shop? Makes me wonder if it would be possible to intentionally drive a company out of business by convincing a bunch of people to use their products incorrectly.
It's not like Fitbit has gigantic text on their web site and product packaging saying "NOT FOR MEDICAL USE." In fact, I challenge you to find any such statement anywhere on their web site. I couldn't, but maybe I suck at it.
They could try a little harder to educate their buyers, here.