Well, they have non-medical versions of their products. What getting the medical device rating means depends on the medical device category. I have no idea how

Well, they have non-medical versions of their products. What getting the medical device rating means depends on the medical device category. I have no idea how Japan works, but for FDA (and they have submitted for FDA approval, they're currently waiting) they've submitted it as a de novo device, which should go ahead and create a brand new product category once (if?) its approved. They do not need clinical trials for their product, but they'll need a bunch of testing to basically assure that they've minimized risk to wearer to an appropriate level, and what that will allow them to do is have doctors prescribe the use of the device (much like how they might tell you use a wheelchair or crutches), and then use, make insurance money available for use. Had they not had medical device clearance, it'd definitely be kinda sketchy (or at least in the grey zone) to have the doctor suggest it for use. Oh, and ya, the regs are going to such. They've submitted in November 2014 and still don't have approval and are expecting to be March 2016. This is rather long, but not really unexpected given their novelty. I really hope that they knew what they were getting into and wrote all their code with the regs in mind. My experience has been that code written from scratch with knowledge of the regs and process is much better than trying to retrofit old code into the framework. It's not easy by any stretch and its still a burden... but its so much less rage inducing.