RemSleep Holdings Inc (RMSL): Website does not say whether it's FD...

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Re: Jugas post# 22482

Sunday, 12/15/2019 11:19:44 AM

Sunday, December 15, 2019 11:19:44 AM

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.

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