Quote from: toolucky98 on December 19, 2017, 10:40:30 PM

Quote from: niklasmato on December 19, 2017, 10:15:57 PM

Quote from: weekofcrypto on December 19, 2017, 07:53:46 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.

I wouldn't think FDA approval is needed, but I bet they need a disclaimer about the results not being medical recommendations and to consult a doctor first.

Yes this is really needed, if not they will be sued by everyone in the US

Consult to a doctor after the checkup is the important thing.
The rresult of the HealthMonitor is just to be more aware.

This device is registered as an electrical device and is certified accordingly. Therefore, it is said that only the doctor will put the exact diagnosis. Everything is done correctly, you understand what I mean Wink