For Healthcare Providers

Help your patients understand their data and engage in their health.

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As access to rich health data through consumer wearables becomes commonplace, your patients may ask for help understanding the data from their Fitbit devices. You may also want to learn about how wearables can allow your patients to better track their health.

Our team of physicians with expertise in cardiology, sleep medicine, neurology and sports medicine created this resource to help you learn about key Fitbit device features and metrics to help you better serve your patients.

This page outlines wellness features as well as the indications of use of regulated features (FDA approved) particularly as it pertains to heart health in the United States. If you are outside the US, please see here for Global user manuals or contact us for more information. It is not meant to be exhaustive but rather a quick resource to give you more context.

Heart Rhythm Features

These features are clinically validated and cleared for use by notified bodies in select countries.

ECG for Heart Rhythm Assessment

What is it?

A user can acquire a 30-second single-lead electrocardiogram (ECG) and get a heart rhythm assessment of Sinus Rhythm, Atrial Fibrillation (AFib), or Inconclusive based on a FDA-cleared software algorithm (sensitivity 98.7%, specificity 100%).

How does it work?

  • Fitbit Sense and Charge 5 have electrodes on the bottom and side(s) of the device so when the user places their finger(s) on the side(s) of the device the electrical signal between

  • There are 3 types of Inconclusive reports: Inconclusive: Low Heart Rate when the HR is too low (<50 bpm); Inconclusive: High Heart Rate when the HR is too high (>120 bpm); and Inconclusive: Didn’t Get A Good Reading when the ECG signal is low or noisy.

  • It does not analyze for other heart rhythms. See Fitbit’s ECG App Physician’s Guide.

Indications for Use (US):

  • The Fitbit ECG App is FDA-cleared (K200948) as “a software-only mobile medical application intended for use with Fitbit wrist wearable devices to create,

  • The AFib detection feature is not recommended for users with other known arrhythmias. The Fitbit ECG App is intended for over-the-counter (OTC) use.

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Irregular Heart Rhythm Notifications

What is it?

The Fitbit Irregular Heart Rhythm Notifications (IHRNs) feature analyzes pulse rate data during inactivity and sends a notification to the user when it detects sig

How does it work?

Fitbit wearables can have optical sensors for photoplethysmography (PPG). PPG detects the increase in blood volume in the skin with each heartbeat to detect the pulse

Indications for Use (US):

  • The FDA-cleared software algorithm is indicated for adults (22 or older) without a prior diagnosis of AFib while most patients deve

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Wellness Features

These features are not intended to inform the diagnosis or treatment of a disease.

Low and High Heart Rate Notifications

What is it?

A low or high heart rate (HR) notification is triggered when the Fitbit wearable detects a HR outside the low or high thresholds and the user appears to be inactive for 10 minutes.

How does it work?

Fitbit wearables can have optical sensors for photoplethysmography (PPG). PPG detects the increase in blood volume in the skin with each heartbeat to d

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Irregular Heart Rhythm Notifications

What is it?

The Nighttime SpO2 feature is a single point estimate of the average blood oxygen saturation across an entire session of sleep. It is derived from optical sensors shining red and infrared light on the wrist and measuring the ratio of the reflected light.

How does it work?

Certain Fitbit wearables have both red and infrared optical sensors for photoplethysmography (PPG), similar to finger-based pulse oximetry machines. The ratio of red and infrared light reflected from the wrist is related to the proportion of oxygenated hemoglobin and is used to estimate SpO2. The average estimated SpO2 during sleep and Estimated Oxygen Variation are calculated after the user wakes.

Interpretation:

Estimated Nighttime SpO2 during sleep is typically >90% but can be low due to breathing abnormalities or other health conditions, high altitude, or physical factors affecting blood flow to the wrist. Variation in blood oxygen during sleep is typically low, so high variation may indicate disturbed breathing.

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Sleep Duration

What is it?

Sleep duration is the estimated amount of time an individual spent sleeping in their main sleep period. By tracking their daily sleep duration

How does it work?

Fitbit can estimate sleep and wake from a variety of signals coming from the device, including accelerometer-derived activity levels and wrist photoplethysmography-derived heart rate patterns (such as sleep-related reductions in heart rate and increases in heart rate variability).

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