Replies to post #22482 on RemSleep Holdings Inc (RMSL)

[rancher64]

Website does not say whether it's FDA approved.

As far as I know a CPAP machine is a Class II medical device, so it needs approval. However DeltaWave is not the full CPAP machine, rather it's the interface, e.g. a component of CPAP machine and works with most of the available CPAP machines. So my understanding is FDA approval needed as DeltaWave is used for breathing.