FDA.reportPublic FDA data

Google Irregular Rhythm Notifications

Primary DI
00810028737778
Brand
Google Irregular Rhythm Notifications
Company
Fitbit LLC
Model
GA13099
Published
2026-05-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
QDBPhotoplethysmograph Analysis Software For Over-The-Counter Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QDBPhotoplethysmograph Analysis Software For Over-The-Counter UseCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212372000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212372000Fitbit Irregular Rhythm NotificationsFitbit, Inc.2022-04-08QDB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810028737778PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810028737778008100287377788100287377780810028737778

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary physiological parameter analysis software, professional-onlyA software program designed to add image processing and/or data analysis capabilities to a computer/workstation for the interpretation and/or screening of cardiopulmonary physiological parameters [e.g., electrocardiogram (ECG), blood pressure, vital capacity (VC)]; data may be uploaded, or collected in real-time by connection (e.g., wired, Bluetooth) to other devices for spot-checks and/or continuous monitoring. It is intended for use exclusively by healthcare professionals and may provide risk assessment for cardiopulmonary events [e.g., acute myocardial infarction (AMI)] or screen for specific conditions (e.g., low ejection fraction). It might include machine learning (ML) technology.

Regulatory Flags#

DUNS number
829454672
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810028737815Google ECG AppGA130982026-05-20
00810038852720 Fitbit Irregular Rhythm NotificationsFB604FB6042022-04-25
00810038851983Fitbit ECG AppFB6032020-10-07
00810073612327Body Temperature Sensing SoftwareFB611FB6112025-09-16
00810073612334Loss of Pulse DetectionFB612FB6122025-09-16
00898628002038AriaFB201WFB201W2016-10-21
00898628002045AriaFB201BFB201B2016-10-21
00816137020800Aria 2 Wi-Fi Smart Scale FB202FB202BK2017-10-25
00816137020831Aria 2 Wi-Fi Smart Scale FB202 FB202WT2017-10-25
00810351028895AriaFB201B2FB201B22016-10-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08806094948233Samsung ECG App v 1.3 (ECG)Samsung Electronics Co., Ltd.QDB2025-06-10
08806094948240Samsung ECG App v 1.3 (ECG)Samsung Electronics Co., Ltd.QDB2025-06-10
08806094940756Samsung ECG Monitor Application with Irregular Heart Rhythm NotificationSamsung Electronics Co., Ltd.QDB2023-10-23
08806094940763Samsung ECG Monitor Application with Irregular Heart Rhythm NotificationSamsung Electronics Co., Ltd.QDB2023-10-23
00194252456798Atrial Fibrillation History FeatureAPPLE INC.QDB2022-09-12
00194252456804Atrial Fibrillation History FeatureAPPLE INC.QDB2022-09-12
00810038852720 Fitbit Irregular Rhythm NotificationsFitbit LLCQDB2022-04-25
00194252456774Irregular Rhythm Notification feature 2.0APPLE INC.QDB2022-03-14
00194252456781Irregular Rhythm Notification feature 2.0APPLE INC.QDB2022-03-14
00190198909510Irregular Rhythm NotificationsAPPLE INC.QDB2019-01-14
00190198909527Irregular Rhythm Notifications APPLE INC.QDB2019-01-14