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Non-invasive measurement of systolic pressure (SYS), diastolic pressure (DIA), heart rate (HR), heart rate variability (HRV), and irregular heartbeats (IrrHB) for professionals 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.

The non-invasive blood pressure measuring system HRVWatch-Mini Wrist Monitor is a smaller size variation of the HRVWatch Wrist Monitor (K123130) previously cleared by FDA in 2013. Identical to its larger-size predecessor in terms of device main functions, the Mini monitor measures blood pressures (BP) (systolic pressure SYS and diastolic pressure DIA) and heart rate (HR), using the oscillometric method commonly employed by electronic blood pressure meters. In addition, the device utilizes piezo-electrical sensors embedded in the cuff (wrist band) to obtain detailed radial arterial waveforms. The 5-minute continuous waveform recording allows the device to detect and report irregular heartbeats. Heart rate variability (HRV) parameters are also obtained by time- and frequency-domain statistical analyses of pulse peak intervals. The main body of the device with its biosensors and electrical circuit boards has the full function of signal acquisition, analysis, and data storage. The testing by the device is controlled by a software programs (app) installed in a smart phone or tablet (the collateral device) via two-way blue-tooth communication. The display of the collateral device (phone or tablet) is used to show live test data plots during test, or post-test data reports and plots. Test data can be uploaded to cloud using the collateral device's internet connectivity. HRVWatch-Mini Wrist Monitor is intended to provide only patient parameter measurements and associated rankings based upon established standard values, and is not intended to produce any clinical interpretation of those measurements or any kind of diagnosis.

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 under the supervision of a trained professional. The device is not intended for ambulatory use. The device is designed for wearing on the left wrist only. 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.

The non-invasive blood pressure measuring system HRVWatch Wrist Monitor measures blood pressures (BP) (systolic pressure SYS and diastolic pressure DIA) and heart rate (HR), using the oscillometric method commonly employed by electronic blood pressure meters. In addition, the device utilizes piezo-electrical sensors embedded in the cuff to obtain detailed radial arterial waveforms. The 5-minute continuous waveform recording allows the device to detect and report irregular heartbeats. Heart rate variability (HRV) parameters are also obtained by time- and frequency-domain analyses of peak-to-peak intervals. The main body of the device has the full functions of testing, display, and data storage. A mini-USB port is provided for connection and data download to a PC. A device-specific software, HRVWatch Manager, is included in the product package for database management and report printing running on a Windows-based PC. HRVWatch Wrist Monitor is intended to provide only patient parameter measurements and is not intended to produce any interpretation of those measurements or any kind of diagnosis.