I dont think FDA approval is needed, its usually for new drugs or medical product, not medical devices. HEALTH MONITOR is made for medical diagnostic so no problem for the safety of people using it.
Exactly, Health Monitor is a medical device. But I am sure there are FDA requirements for medical devices as well.
Well, it's clearly said in their FAQ that Health Monitor is not a certified medical device but is classified just as an electrical device.
You're right, the FDA regulates also medical devices and is quite strict as far as I know.
It takes min. 2 years to get a medical certification and we want to go to market way before. That's why we are now branding our machine as a non-medical device.