Physiology/motion recording wristband

Intended purpose

The product is intended to measure, review and store adults’ ECG data at home or in healthcare environment, does not contain an auto-analysis function. The ECG recorder is intended to record, display, store and transfer single-channel electrocardiogram(ECG) rhythms at home or in healthcare environment. The device does no analysis by itself and is intended to be used with a compatible ambulatory ECG (Holter) analysis system (AI-ECG Tracker) which will analyze the recorded data. The device data and the data analysis are then reviewed by trained medical personnel for the purpose of forming a clinical diagnosis. The device is intended for use by adults’ health-conscious individuals. The product does not include analysis and diagnosis functions. The product has not been tested and it is not intended for pediatric use.