Fitbit ECG App

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref FB603

by Fitbit LLC

Identity

Trade Name: Fitbit ECG App EUDAMEDFDA UDI
Generic Name: Cardiopulmonary physiological parameter analysis software FDA UDI
Device Name: Fitbit ECG App EUDAMED
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 AF detection function 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 ECG Spot Check 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 is 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 FDA UDI
Model / Reference: FB603 EUDAMEDFDA UDI
Description: 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 AF detection function 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 ECG Spot Check 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 is 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 FDA UDI

Identifiers

Primary DI / UDI-DI: 00810038851983 EUDAMEDFDA UDI
Basic UDI-DI: B-00810038851983 EUDAMED
081003885FB603R8 EUDAMED
Direct Marketing DI: 00810038851983 EUDAMED
510(k) Number: K200948 FDA UDI
FDA Product Code: QDA FDA UDI
EMDN Code: Z12050382 ELECTROCARDIOGRAPHS - SOFTWARE ACCESSORIES EUDAMED
GMDN Term: Cardiopulmonary physiological parameter analysis software FDA UDI

Classification

Device Class: Class IIa EUDAMED
Class II FDA UDI
Regulation Number: 870.2345 FDA UDI
Special Device Type: -1192 EUDAMED
Software EUDAMED
Market of Registration: Northern Ireland EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Fitbit ECG App by Fitbit LLC — Class IIa — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

European Union Active

CE/MDD

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDR	B-00810038851983	Class IIa	Active
EUDAMED	European Union	CE/MDD	B-00810038851983	Class IIa	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class IIa	Pending data

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Manufacturer

Manufacturer: Fitbit LLC
EUDAMED SRN: US-MF-000007439
Authorised Representative: Emergo Europe B.V. NL-AR-000000116

Sources (3)

EUDAMED f576c66b-0e45-42be-b71f-2e20bdb804e2 61 fields · synced Jul 22, 2026
EUDAMED 9c466515-fc8b-4032-a2d5-856f593aaed4 61 fields · synced May 17, 2026
FDA UDI 5002e376-4e5d-4697-9a47-c813f290adfc 35 fields · synced May 30, 2026