RemSleep Holdings Inc (RMSL)

[rancher64]

Products available to Buy. Class I-exempt from 510K?
I see DeltaWave and SleepWave could be purchased from RMSL website.

DeltaWave $125.00
SleepWave $849.00

FDA classified medical devices into 3 categories.

Class I : minimum harm to users, 510K approval not required.
Class II & III : 510K approval needed.

My understanding is both DeltaWave and SleepWave are Class I type otherwise it could not be sold without 510K clearance. Correct me if I am wrong.


My own DD, do your own.