Fitbit Irregular Rhythm Notifications

Primary DI

00810038852720

Basic UDI-DI Code

081003885FB604RA

Reference

FB604

Device Types

None provided

Regulation

Eu Mdr

Classification

Eu Md Class 2a

Status

On The Market

Manufacturer

Fitbit LLC

The Fitbit Irregular Rhythm Notifications feature is used to track and analyze pulse rhythm data for irregularities in beat-to-beat measurements, which can be indicative of AFib. Heart-rhythm data are temporarily stored on your consumer wrist-worn product until the data sync to your account. If signs of AFib are found in the data, you’ll receive a notification on your phone to view details of the findings in the Fitbit app. The data are not analyzed in real-time and are not intended for diagnostic purposes.

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