Organization name

Fitbit LLC

SRN

US-MF-000007439

Manufacturer status

Active

9 warnings recorded — scroll inside the panel to see all entries.

• The assessment carried out by this product is NOT a diagnosis.

  OTHER

• This product is NOT intended for use in a clinical setting.

  OTHER

• DO NOT interpret or take clinical action solely based on the notification without consultation of a qualified healthcare professional.

  OTHER

• The feature has not been tested for and is not intended for use in people under 22 years of age. The feature is not intended for use for people with a history or diagnosis of atrial fibrillation.

  OTHER

• DO NOT change your medication without first speaking to your doctor. The results of the Fitbit Irregular Rhythm Notifications may not be accurate in people who take medication or substances that affect heart rate or blood flow.

  OTHER

• DO NOT use this product in place of treatment prescribed by your doctor. Palpitations and shortness of breath can be symptoms of AFib, but some people don’t have any symptoms. AFib is treatable, so the earlier you detect it, the sooner you and your doctor can do something about it.

  OTHER

• DO NOT use for clinical diagnosis of AFib.

  OTHER

• DO NOT use for continuous, real-time monitoring of heart rhythm.

  OTHER

• This product CANNOT detect heart attack, blood clots, stroke, or other heart conditions.

  OTHER

Primary placement in Netherlands; available across 17 countries total.

Trade name

Google Irregular Rhythm Notifications

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

00810028737778

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

081003885FB604RA

Reference / catalog number

GA13099

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

Class IIa

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

The Irregular Rhythm Notifications feature is used to track and analyze pulse rhythm data for irregularities in beat-to-beat measurements, which can be indicative of AFib. Heart-rhythm data are temporarily stored on your consumer wrist-worn product until the data sync to your account. If signs of AFib are found in the data, you’ll receive a notification on your phone to view details of the findings in the Google Health app. The data are not analyzed in real-time and are not intended for diagnostic purposes.

Additional information URL

https://help.fitbit.com/manuals/manual_ecg_en_US.pdf

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• Z12050382ELECTROCARDIOGRAPHS - SOFTWARE ACCESSORIES

• Class IIa medical devices in Europe

No certificate specifically references this device's Basic UDI-DI.

Certificate health across this manufacturer's portfolio.