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Fitbit Irregular Rhythm Notifications

FDA UDI

Class II (US FDA UDI)

by Fitbit LLC

Identity

Trade Name
Fitbit Irregular Rhythm Notifications FDA UDI
Generic Name
Cardiopulmonary physiological parameter analysis software FDA UDI
Device Name
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. FDA UDI
Model / Reference
FB604 FDA UDI
Description
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. FDA UDI

Identifiers

Catalog Number
FB604 FDA UDI
Primary DI / UDI-DI
00810038852720 FDA UDI
510(k) Number
K212372 FDA UDI
FDA Product Code
QDB FDA UDI
GMDN Term
Cardiopulmonary physiological parameter analysis software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.2790 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Cardiopulmonary physiological parameter analysis software

Fitbit Irregular Rhythm Notifications by Fitbit LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiopulmonary physiological parameter analysis software.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Fitbit LLC

Sources (1)

  • FDA UDI a8b73ee3-6fb0-41e1-888f-e32d0869c7cd 36 fields · synced May 31, 2026