# K200948: Fitbit ECG App

- Pathway: 510(k) (Traditional)
- Applicant: Fitbit, Inc.
- Decided: Sep 11, 2020 after 156 days
- Product code: QDA (Electrocardiograph Software For Over-The-Counter Use)
- Device class: 2
- Regulation: 21 CFR 870.2345
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN180044 (2018). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN180044: ECG App, Apple, Inc. (2018) Summary page 4.

## Indications for use
The Fitbit ECG App is a software-only mobile medical application intended for use with Fitbit wrist wearable devices to create, record, store, transfer, and display a single channel electrocardiogram (ECG) qualitatively similar to a Lead I ECG. The Fitbit ECG App determines the presence of atrial fibrillation (AFib) or sinus rhythm on a classifiable waveform. The AFib detection feature is not recommended for users with other known arrhythmias. The Fitbit ECG App is intended for over-the-counter (OTC) use. The ECG data displayed by the Fitbit ECG App is intended for informational use only. The user is not intended to interpret or take clinical action based on the device output without consultation of a qualified healthcare professional. The ECG waveform is meant to supplement rhythm classification for the purposes of discriminating AFib from normal sinus rhythm and not intended to replace traditional methods of diagnosis or treatment. The Fitbit ECG App is not intended for use by people under 22 years old.

Source page: https://510kreport.com/device/K200948
Methodology: https://510kreport.com/methodology