When doing customer research and sharing my wearable tech product concept with people, I'm often asked if it could be used to treat hot flashes. I've always said no - it is designed to improve building energy efficiency and so no medical claims are being made for it.
But today I came across the "ambi" device which has a page devoted to hot flashes (http://myambi.com/en/content/2-hot-flashes). So, to me, it seems like ambi is a medical device and would need to go through the 510(k) process. But the manufacturer also says "The benefits of ambi(TM) have not been evaluated by the US FDA or other regulatory authority. ambi(TM) makes no medical claims to treat, cure or prevent any disease or medical condition."
Can you really have it both ways like this: marketing like a medical device but not going through the FDA 510(k) process? Is this really not a medical device at all? Or are they skating on thin ice by talking about hot flashes and then slipping in this disclaimer?
I'd love to get an answer so I can be sure I'm not missing a market opportunity.