Fitbit Irregular Rhythm Notifications - The Fitbit Irregular Rhythm Notifications is a - FITBIT, INC.

Duns Number:829454672

Device Description: The Fitbit Irregular Rhythm Notifications is a software-only mobile medical application th 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 usein people under 22 years of age. It is also not intended for use in individuals previouslydiagnosed with AFib.

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More Product Details

Catalog Number

FB604

Brand Name

Fitbit Irregular Rhythm Notifications

Version/Model Number

FB604

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K212372

Product Code Details

Product Code

QDB

Product Code Name

Photoplethysmograph Analysis Software For Over-The-Counter Use

Device Record Status

Public Device Record Key

a8b73ee3-6fb0-41e1-888f-e32d0869c7cd

Public Version Date

October 14, 2022

Public Version Number

3

DI Record Publish Date

April 25, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"FITBIT, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 7