Quote from: maurobiasolo on December 19, 2017, 04:13:33 PM

Quote from: Jay2408 on December 19, 2017, 02:36:37 PM

Quote from: Sozialtourist on December 19, 2017, 02:21:41 PM

Quote from: openair on December 19, 2017, 01:25:09 PM

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.

Are you planning to get a FDA approval though?
As far as I understand, requirements for medical devices are much higher, hence it would be important for a lot of customers to know that it's FDA approved and that it fits all the standards.