Physiology/motion recording wristband

Intended purpose

The device is a medical device composed of software and the dedicated hardware of a reusable wrist applied device, which incorporates a single-lead electrocardiograph (ECG) and a reflectance photoplethysmograph (PPG). It is intended for intermittent measurements. The device measures, transfers, records, and displays lead I of an ECG. It calculates the heart rate and detects the presence of AF or sinus rhythm on a classifiable ECG waveform. The device measures, transfers, records and displays pulse rate to identify episodes of irregular heart rhythm suggestive of AF and provides a notification to the user. It can be used to supplement a clinician’s decision to screen for possible AF. The device is indicated for over-the-counter (OTC) use in adults. The device is not recommended for users with other known arrhythmias. The companion app allows the device installation and displays the results of performed measurements.