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Keep It Simple with NeoRhythm App

NeoRhythm is registered as a general wellness device, but it is compliant with the EU Medical Device Regulation: Regulation (EU) 2017/745, Annex XVI, which sets the safety and performance requirements for devices of both medical and non-medical purposes.

In the US NeoRhythm is positioned as a general wellness device compliant with FDA regulation (General Wellness: Policy for Low Risk Devices: 2019-09-17)NeoRhythm has not been evaluated by the FDA. These products do not claim todiagnose, treat, cure, or prevent any medical condition. Always consult your medical doctor regarding any health concerns.