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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.

But it will remain forever a non-medical device or you're going to rebrand it to medical device in the future, or maybe you gonna brand the next version as medical?

Eventually, it should get the medical certification, it will take some years, so meanwhile, they are not cranching it as medical, until the certification is approved, then it will, its what I would do, 2 years or so is a lot of time wasted.

Due to its usefulness and all the renown that will be achieved with demonstrations of operation, will not have difficulty in any type of certification, the visibility that will be provided by the demonstrations and for possible requests of partnerships with Companies of the medical branch, this will be applicable without problems , and for this reason I will be together and count on good earnings from HealthMonitor