This app-driven system works with HRVWatch-Mini Wrist Monitor for measuring blood pressure, heart rate, heart rate variability (HRV; related to the functions of the autonomic nervous system), and irregular heartbeats (including arrhythmias). Each test lasts 6 minutes. Wearing on your left or right wrist while sitting or lying down, the test progress with pulse waves is shown on the smart phone's screen. The finished test report is automatically saved in the phone so that you can view your self, show or share with your doctors (via e-mail).
Hardware Device Name: HRVWatch-Mini Wrist Monitor
US FDA Indications for Use: Non-invasive measurement of systolic pressure (SYS), diastolic pressure (DIA), heart rate (HR), heart rate variability (HRV), and irregular heartbeats (IrrHB) for professionals at office or patients at home. The device is not intended for ambulatory use. The device has not been tested and it is not intended for pediatric use. The device provides a HRV parameter which is only mathematical analysis and is not intended to produce any interpretation of those measurements or any kind of diagnosis.
Prescription Use __■_____
(Part 21 CFR 801 Subpart D) AND Over-The-Counter Use ___■______
(21 CFR 801 Subpart C)
Hardware Device Name: HRVWatch-Mini Wrist Monitor
US FDA Indications for Use: Non-invasive measurement of systolic pressure (SYS), diastolic pressure (DIA), heart rate (HR), heart rate variability (HRV), and irregular heartbeats (IrrHB) for professionals at office or patients at home. The device is not intended for ambulatory use. The device has not been tested and it is not intended for pediatric use. The device provides a HRV parameter which is only mathematical analysis and is not intended to produce any interpretation of those measurements or any kind of diagnosis.
Prescription Use __■_____
(Part 21 CFR 801 Subpart D) AND Over-The-Counter Use ___■______
(21 CFR 801 Subpart C)
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