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U.S. Department of Health and Human Services

Product Classification

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Device electrocardiograph software for over-the-counter use
Regulation Description Electrocardiograph software for over-the-counter use.
Definition An electrocardiograph software device for over-the-counter use creates, analyzes, and displays electrocardiograph data, and can provide information for identifying cardiac arrhythmias. This device is not intended to provide a diagnosis.
Physical State The devices uses consumer grade electronics and is hand held or worn on the wrist, arms, or chest.
Technical Method Uses input from leads attached to or in contact with the users hands, wrists, arms, or chest to detect potential differences and generate an ECG waveform.
Target Area Hands, arms, or chest.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeQDA
Premarket Review Office of Cardiovascular Devices (OHT2)
Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A)
Submission Type 510(k)
Regulation Number 870.2345
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible