Vivos Inc (RDGL)

[DreDiZzlE]

"Nor do we believe your device is of low to moderate risk and thus eligible for denovo"

That quote is straight from the fda denovo denial.
They are submitting again thru denovo class 2 even tho the fda clearly states its not the right avenue.

Class 2 examples on fda.gov are condoms, wheelchairs, pregnancy kits, etc.

Class 3 examples "injectable, sustains life ".

Links to government agencies confirm human testing was suggested.

Seems pretty simple.