[twistedpair]

Is the Airing device FDA approved? No, not yet. However, we do believe the process of getting FDA clearance may be abbreviated.

Ha. I work at a company that makes medical devices. It's just so damn easy, you know! Seems like a pretty blunt case of handwaving away this critical step. This is an electric device that controls if you can breath. This thing has a non-trivial risk of hurting someone through electrocution (it's plugged into your conductive mucus) or asphyxiation (though hopefully you'll wake).

So yeah, they'll clearly just POST to the FDA certification API and get a response within a minute.