Atrial Fibrillation History Feature

Primary DI

00194252456804

Basic UDI-DI Code

0194252AFHFeatureCH

Reference

Atrial Fibrillation History Feature V1.X

Device Types

None provided

Regulation

Eu Mdr

Classification

Eu Md Class 2a

Status

On The Market

Manufacturer

Apple Inc.

The Atrial Fibrillation (AFib) History Feature is an over-the-counter (“OTC”) software-only mobile medical application intended for users 22 years of age and over who have a diagnosis of atrial fibrillation (AFib). The feature opportunistically analyzes pulse rate data to identify episodes of irregular heart rhythms suggestive of AFib and provides the user with a retrospective estimate of AFib burden (a measure of the amount of time spent in AFib during past Apple Watch wear). The feature also tracks and trends estimated AFib burden over time, and includes lifestyle data visualizations to enable users to understand the impact of certain aspects of their lifestyle on their AFib. It is not intended to provide individual irregular rhythm notifications or to replace traditional methods of diagnosis, treatment, or monitoring of AFib. The feature is intended for use with the Apple Watch and the Health app on iPhone. Target Population and Intended Users: The AFib History Feature is intended for users who are 22 years and over. The feature is also intended for users that have been diagnosed with atrial fibrillation. Users who are interested in learning more about their cardiovascular health may choose

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