Cardiac electrophysiology application software

Intended purpose

The Fitbit ECG App is a software-only medical device used as a spot check to create, record, display, store and analyze an ECG. The Fitbit ECG App (working name: ECG Spot Check) consists of a Device application (“Device app”) integrated on a consumer Fitbit wrist-worn product and a mobile application tile (“mobile app”) on Fitbit’s consumer mobile application. The Device app uses data from non-medical grade electrical sensors on a consumer Fitbit wrist-worn product to create and record an ECG. The algorithm on the Device app analyzes a 30-second recording of the ECG and provides results to the user. Users are able to view their past results as well as a pdf report of the waveform similar to a Lead I ECG on the mobile app. Intended Purpose: The Fitbit ECG App is intended to allow the user to record a waveform similar to a single lead ECG that is then classified as sinus rhythm or atrial fibrillation (AF) on a classifiable waveform. The ECG and rhythm classification is not recommended for users with other known arrhythmias. The Fitbit ECG App is intended for home use by lay people aged 22 years and over.