Fitbit ECG App

Primary DI

00810038851983

Basic UDI-DI Code

B-00810038851983

Reference

FB603

Device Types

None provided

Regulation

Eu Mdd

Classification

Eu Md Class 2a

Status

On The Market

Manufacturer

Fitbit LLC

The Fitbit ECG software-only medical application is used to create and record an ECG, similar to a single-lead ECG, when you open the Fitbit ECG app, follow the instructions, and place 2 fingers on the electrical sensors. The Fitbit ECG app is qualitatively similar to a Lead I ECG in that it can be used to discriminate between AFib and normal sinus rhythm; it is not intended for diagnostic purposes. The app is a spot check that analyzes the recording and presents the results. The ECG data can be used for non-clinical applications, such as providing an estimate of your heart rate. The ECG recording is temporarily stored in the ECG app on your Fitbit wristworn product until the data syncs to your account; you’re then able to view your results in the Fitbit app on your phone or tablet.

Other on-the-market devices with the same classification (Eu Md Class 2a) and regulation (EU MDD).