Fitbit Irregular Rhythm Notifications FB604

GUDID 00810038852720

The Fitbit Irregular Rhythm Notifications is a software-only mobile medical application that is intended to be used with compatible consumer wrist-worn products to analyze pulse rate data to identify episodes of irregular heart rhythms suggestive of atrial fibrillation (AFib) and provide a notification to the user. The Fitbit Irregular Rhythm Notifications is intended for over-the-counter (OTC) use. It is not intended to provide a notification on every episode of irregular rhythm suggestive of AFib and the absence of a notification is not intended to indicate no disease process is present; rather the Fitbit Irregular Rhythm Notifications is intended to opportunistically surface a notification of possible AFib when sufficient data are available for analysis. These data are only captured when the user is still. Along with the user’s risk factors, the Fitbit Irregular Rhythm Notifications can be used to supplement the decision for AFib screening. The Fitbit Irregular Rhythm Notifications is not intended to replace traditional methods of diagnosis or treatment. The Fitbit Irregular Rhythm Notifications has not been tested for and is not intended for use in people under 22 years of age. It is also not intended for use in individuals previously diagnosed with AFib.

FITBIT, INC.

Electrocardiograph, home-use
Primary Device ID00810038852720
NIH Device Record Keya8b73ee3-6fb0-41e1-888f-e32d0869c7cd
Commercial Distribution StatusIn Commercial Distribution
Brand NameFitbit Irregular Rhythm Notifications
Version Model NumberFB604
Catalog NumberFB604
Company DUNS829454672
Company NameFITBIT, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone+1(877) 623-4997
Emailsupport@fitbit.com
Phone+1(877) 623-4997
Emailsupport@fitbit.com
Phone+1(877) 623-4997
Emailsupport@fitbit.com
Phone+1(877) 623-4997
Emailsupport@fitbit.com
Phone+1(877) 623-4997
Emailsupport@fitbit.com
Phone+1(877) 623-4997
Emailsupport@fitbit.com
Phone+1(877) 623-4997
Emailsupport@fitbit.com
Phone+1(877) 623-4997
Emailsupport@fitbit.com
Phone+1(877) 623-4997
Emailsupport@fitbit.com
Phone+1(877) 623-4997
Emailsupport@fitbit.com
Phone+1(877) 623-4997
Emailsupport@fitbit.com
Phone+1(877) 623-4997
Emailsupport@fitbit.com
Phone+1(877) 623-4997
Emailsupport@fitbit.com
Phone+1(877) 623-4997
Emailsupport@fitbit.com
Phone+1(877) 623-4997
Emailsupport@fitbit.com
Phone+1(877) 623-4997
Emailsupport@fitbit.com
Phone+1(877) 623-4997
Emailsupport@fitbit.com
Phone+1(877) 623-4997
Emailsupport@fitbit.com
Phone+1(877) 623-4997
Emailsupport@fitbit.com
Phone+1(877) 623-4997
Emailsupport@fitbit.com
Phone+1(877) 623-4997
Emailsupport@fitbit.com
Phone+1(877) 623-4997
Emailsupport@fitbit.com
Phone+1(877) 623-4997
Emailsupport@fitbit.com
Phone+1(877) 623-4997
Emailsupport@fitbit.com
Phone+1(877) 623-4997
Emailsupport@fitbit.com
Phone+1(877) 623-4997
Emailsupport@fitbit.com
Phone+1(877) 623-4997
Emailsupport@fitbit.com
Phone+1(877) 623-4997
Emailsupport@fitbit.com
Phone+1(877) 623-4997
Emailsupport@fitbit.com
Phone+1(877) 623-4997
Emailsupport@fitbit.com
Phone+1(877) 623-4997
Emailsupport@fitbit.com
Phone+1(877) 623-4997
Emailsupport@fitbit.com
Phone+1(877) 623-4997
Emailsupport@fitbit.com
Phone+1(877) 623-4997
Emailsupport@fitbit.com
Phone+1(877) 623-4997
Emailsupport@fitbit.com
Phone+1(877) 623-4997
Emailsupport@fitbit.com
Phone+1(877) 623-4997
Emailsupport@fitbit.com
Phone+1(877) 623-4997
Emailsupport@fitbit.com
Phone+1(877) 623-4997
Emailsupport@fitbit.com
Phone+1(877) 623-4997
Emailsupport@fitbit.com
Phone+1(877) 623-4997
Emailsupport@fitbit.com
Phone+1(877) 623-4997
Emailsupport@fitbit.com
Phone+1(877) 623-4997
Emailsupport@fitbit.com
Phone+1(877) 623-4997
Emailsupport@fitbit.com
Phone+1(877) 623-4997
Emailsupport@fitbit.com
Phone+1(877) 623-4997
Emailsupport@fitbit.com
Phone+1(877) 623-4997
Emailsupport@fitbit.com
Phone+1(877) 623-4997
Emailsupport@fitbit.com
Phone+1(877) 623-4997
Emailsupport@fitbit.com
Phone+1(877) 623-4997
Emailsupport@fitbit.com
Phone+1(877) 623-4997
Emailsupport@fitbit.com
Phone+1(877) 623-4997
Emailsupport@fitbit.com
Phone+1(877) 623-4997
Emailsupport@fitbit.com
Phone+1(877) 623-4997
Emailsupport@fitbit.com
Phone+1(877) 623-4997
Emailsupport@fitbit.com
Phone+1(877) 623-4997
Emailsupport@fitbit.com
Phone+1(877) 623-4997
Emailsupport@fitbit.com
Phone+1(877) 623-4997
Emailsupport@fitbit.com
Phone+1(877) 623-4997
Emailsupport@fitbit.com
Phone+1(877) 623-4997
Emailsupport@fitbit.com
Phone+1(877) 623-4997
Emailsupport@fitbit.com
Phone+1(877) 623-4997
Emailsupport@fitbit.com
Phone+1(877) 623-4997
Emailsupport@fitbit.com
Phone+1(877) 623-4997
Emailsupport@fitbit.com
Phone+1(877) 623-4997
Emailsupport@fitbit.com
Phone+1(877) 623-4997
Emailsupport@fitbit.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100810038852720 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QDBPhotoplethysmograph Analysis Software For Over-The-Counter Use

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-03
Device Publish Date2022-04-25

Devices Manufactured by FITBIT, INC.

00810038852720 - Fitbit Irregular Rhythm Notifications2022-05-03The Fitbit Irregular Rhythm Notifications is a software-only mobile medical application that is intended to be used with compatible consumer wrist-worn products to analyze pulse rate data to identify episodes of irregular heart rhythms suggestive of atrial fibrillation (AFib) and provide a notification to the user. The Fitbit Irregular Rhythm Notifications is intended for over-the-counter (OTC) use. It is not intended to provide a notification on every episode of irregular rhythm suggestive of AFib and the absence of a notification is not intended to indicate no disease process is present; rather the Fitbit Irregular Rhythm Notifications is intended to opportunistically surface a notification of possible AFib when sufficient data are available for analysis. These data are only captured when the user is still. Along with the user’s risk factors, the Fitbit Irregular Rhythm Notifications can be used to supplement the decision for AFib screening. The Fitbit Irregular Rhythm Notifications is not intended to replace traditional methods of diagnosis or treatment. The Fitbit Irregular Rhythm Notifications has not been tested for and is not intended for use in people under 22 years of age. It is also not intended for use in individuals previously diagnosed with AFib.
00810038852720 - Fitbit Irregular Rhythm Notifications2022-05-03 The Fitbit Irregular Rhythm Notifications is a software-only mobile medical application that is intended to be used with compati
00810038851983 - Fitbit ECG App2020-10-15 The Fitbit ECG App is a software-only mobile medical application intended for use with Fitbit wrist-wearable devices to create,
00810351028895 - Aria2018-10-31 The ARIA WiFi Smart Scale uses the Bioelectrical Impedance Analysis (BIA) technique to measure body fat composition by sending a
00816137020800 - Aria 2 Wi-Fi Smart Scale 2018-03-29 The Aria 2 Wireless Smart Scale is a body analyzer that measures body weight and uses bioelectrical impedance analysis (BIA) tec
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