There are other posts here and on Twitter and StockTwits implying sales of non-FDA approved medical devices which is enough to warrant an FDA and SEC investigation.
I'm not sure how it would even be legal to ship non FDA approved samples as someone has already pointed out the safety concerns:
mdaysurf13 12:35 PM @LapuaTrader I would think they cannot send samples. This is a medical device for people during sleep, could be dangerous and maybe even fatal if not calibrated right.
Only sample would be during trials but those are controlled settings.
Someone with expertise in this area should comment! I will research it more, internet is a wonderful thing