Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

Intended purpose

The Blood pressure monitor is intended to record, store, display and transfer single-channel electrocardiogram (ECG), blood pressure and pulse rate in adult population. 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 (used under the care of a physician). 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 device does not include analysis and diagnosis functions. The device has not been tested and it is not intended for pediatric use.