[Caligula]

I am curious, does your certification and testing involve anything with the FDA?

I worked at one of the big sleep companies before and we always had to adhere to FDA regulations even though we were careful to be 'monitoring' and not 'diagnosis/treatment'. The FDA also occasionally randomly popped in as a part of their standard monitoring process.

[jrockway]

I think they are careful to say "this is not a medical device", which exempts them from regulation. They can market it as a fun toy or fashion accessory or whatever, and then it has nothing to do with medicine.