Fitbit ECG App

Q: When was Fitbit ECG App cleared by the FDA?

Fitbit ECG App (K200948) received a 510(k) decision of Substantially Equivalent on September 11, 2020, 156 days after the submission was received.

Q: What is the product code of K200948?

The FDA product code is QDA – Electrocardiograph Software For Over-The-Counter Use, a Class II (moderate risk) device regulated under 21 CFR 870.2345.

FDA 510(k) K200948 · Fitbit, Inc.

Substantially Equivalent

510(k) numberK200948

Submission

Device name: Fitbit ECG App
Applicant: Fitbit, Inc.
San Francisco, CA, US
Received: April 8, 2020
Decision date: September 11, 2020
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: QDA – Electrocardiograph Software For Over-The-Counter Use
Device class: Class II (moderate risk)
Regulation: 21 CFR 870.2345
Specialty: Cardiovascular

An electrocardiograph software device for over-the-counter use creates, analyzes, and displays electrocardiograph data, and can provide information for identifying cardiac arrhythmias. This device is not intended to provide a diagnosis.

Other 510(k)s with product code QDA

510(k)	Device	Applicant	Decision
K240795	Withings ECG AppQDA · Traditional	Withings	06/15/2025SE
K243236	WHOOP ECG (electrocardiogram) Feature (1.0)QDA · Traditional	Whoop., Inc.	04/04/2025SE
K240909	Samsung ECG App v 1.3 (ECG)QDA · Traditional	Samsung Electronics Co., Ltd.	08/02/2024SE
K230292	Samsung ECG Monitor Application with Irregular Heart Rhythm NotificationQDA · Traditional	Samsung Electronics Co., Ltd.	05/02/2023SE
K221774	Garmin ECG AppQDA · Traditional	Garmin International, Inc.	01/12/2023SE
K201525	ECG AppQDA · Traditional	Apple, Inc.	10/08/2020SE
K201168	ECG Monitor AppQDA · Traditional	Samsung Electronics Co., Ltd.	08/04/2020SE

More from Samsung Electronics Co., Ltd.

510(k)	Device	Decision
K242967	Loss of Pulse DetectionSDY · Traditional	02/25/2025SE
K243778	Body Temperature Software (BTS)QZA · Special	02/13/2025SE
K212372	Fitbit Irregular Rhythm NotificationsQDB · Traditional	04/08/2022SE
K133872	Aria Wifi Smart ScaleMNW · Traditional	06/02/2014SE

Questions and answers

When was Fitbit ECG App cleared by the FDA?

Fitbit ECG App (K200948) received a 510(k) decision of Substantially Equivalent on September 11, 2020, 156 days after the submission was received.

What is the product code of K200948?

The FDA product code is QDA – Electrocardiograph Software For Over-The-Counter Use, a Class II (moderate risk) device regulated under 21 CFR 870.2345.