fitbit.comLoss of Pulse Detection
Fitbit
FITBIT LLC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3009253624 | 3009253624 | FITBIT LLC | 1 | N | 2026-01-01 | 215 Fremont St San Francisco CA US 94105 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00810038851983 | Fitbit ECG App - The Fitbit ECG App is a software-only mobile medical application intended for use with Fitbit wrist-wearable devices to create, record, store, transfer, and display a single channel electrocardiogram (ECG) qualitatively similar to a Lead I ECG. The Fitbit ECG App determines the presence of atrial fibrillation (AFib) or sinus rhythm on a classifiable waveform. The AF detection function is not recommended for users with other known arrhythmias.The Fitbit ECG App is intended for over-the-counter (OTC) use. The ECG data displayed by the ECG Spot Check isintended for informational use only. The user is not intended to interpret or take clinical action based on the device output without consultation of a qualified healthcare professional. The ECG waveform is meant to supplement rhythm classification for the purposes of discriminating AFib from normal sinus rhythm and is not intended to replace traditional methods of diagnosis or treatment. The Fitbit ECG App is not intended for use by people under 22 years old | +1(877) 623-4997 | support@fitbit.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 140913 | 1009791890 | K243778 | Body Temperature Software (BTS) | QZA | 2025-02-13 |
| 140913 | 1652331740 | K242967 | Loss of Pulse Detection | SDY | 2025-02-25 |
| 140913 | 1146281917 | K212372 | Fitbit Irregular Rhythm Notifications | QDB | 2022-04-08 |
| 140913 | 1878176023 | K200948 | Fitbit ECG App | QDA | 2020-09-11 |
| 140913 | 1542823052 | K133872 | ARIA WIFI SMART SCALE | MNW | 2014-06-02 |
| 140913 | 1688062605 | DEN230050 | Body Temperature Software (BTS) | QZA | 2023-12-15 |
| 140913 | 1137878090 |
Product Codes Associated With Registrations#
PMN#
Fitbit Irregular Rhythm Notifications
Fitbit Inc
Fitbit ECG App
Fitbit, Inc.
ARIA WIFI SMART SCALE
FITBIT, INC.
GUDID#
Google Irregular Rhythm Notifications - GA13099
2026-05-20
Google ECG App - GA13098
2026-05-20
Fitbit Irregular Rhythm Notifications - 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.
2022-04-25
Fitbit ECG App - The Fitbit ECG App is a software-only mobile medical application intended for use with Fitbit wrist-wearable devices to create, record, store, transfer, and display a single channel electrocardiogram (ECG) qualitatively similar to a Lead I ECG. The Fitbit ECG App determines the presence of atrial fibrillation (AFib) or sinus rhythm on a classifiable waveform. The AF detection function is not recommended for users with other known arrhythmias.The Fitbit ECG App is intended for over-the-counter (OTC) use. The ECG data displayed by the ECG Spot Check isintended for informational use only. The user is not intended to interpret or take clinical action based on the device output without consultation of a qualified healthcare professional. The ECG waveform is meant to supplement rhythm classification for the purposes of discriminating AFib from normal sinus rhythm and is not intended to replace traditional methods of diagnosis or treatment. The Fitbit ECG App is not intended for use by people under 22 years old
2020-10-07
Body Temperature Sensing Software - The Body Temperature Software (BTS) is a mobile medical application available to its intended users via their mobile device. The Body Temperature Software (BTS) collects and analyzes temperature data obtained via the infrared sensor built into the smartphone to approximate the user's rectal temperature which is then displayed on the application's user interface. The Body Temperature Software (BTS) is a pre-installed application on the Pixel 8 Pro with Android 14 operating system release or higher.
2025-09-16
Loss of Pulse Detection - The Loss of Pulse detection SaMD is intended to be used for the detection of loss of pulse using photoplethysmography (PPG) and accelerometer sensors present in a wrist worn consumer wearable device. Upon detection of loss of pulse, when the smartwatch is worn, the feature will prompt haptic and audio alerts and notifications to the user and prompt the user’s compatible hardware to call emergency services if the user is unresponsive to the notifications and alerts. This is an opt-in feature and will be offby default.
2025-09-16
Aria - The ARIA WiFi Smart Scale uses the Bioelectrical Impedance Analysis (BIA) technique to measure body fat composition by sending a low, safe electrical current throughout the body (“foot-to-foot”). The current passes through muscle tissue with lower resistance than through fat tissue. The resistance in fat tissue is termed “bioelectrical impedance” and is the principle of operation for the ARIA scale measurement. The ARIA scale displays the measurement results to the user on a large display that is backlit and easy to read from the standing position. Measurement results include body weight (lb, kg, stone) and body fat (percentage). The scale stores up to 16 readings. The scale is battery operated (4-AA batteries). Prior to use, the user creates a confidential profile on the Fitbit website (which is only available to the user unless affirmatively shared by the user with other users). The scale has an added functionality of wirelessly transmitting the readings to the user’s profile for trending. The user profile is stored locally on the scale, so that the functionality of the scale is autonomous after initial setup.Up to eight (8) users may create profiles to use a single scale. The scale has an automatic recognition function, where it recognizes the user based on the user’s previous weight and profile. If two users have similar body weight profiles, they will be prompted to identify themselves using their initials at the time of weight measurement (selection by tapping the appropriate side of the scale).The complementary interface with the Fitbit website allows the user to view their body weight and body fat trend data over time.
2016-10-21
Aria - The ARIA WiFi Smart Scale uses the Bioelectrical Impedance Analysis (BIA) technique to measure body fat composition by sending a low, safe electrical current throughout the body (“foot-to-foot”). The current passes through muscle tissue with lower resistance than through fat tissue. The resistance in fat tissue is termed “bioelectrical impedance” and is the principle of operation for the ARIA scale measurement. The ARIA scale displays the measurement results to the user on a large display that is backlit and easy to read from the standing position. Measurement results include body weight (lb, kg, stone) and body fat (percentage). The scale stores up to 16 readings. The scale is battery operated (4-AA batteries). Prior to use, the user creates a confidential profile on the Fitbit website (which is only available to the user unless affirmatively shared by the user with other users). The scale has an added functionality of wirelessly transmitting the readings to the user’s profile for trending. The user profile is stored locally on the scale, so that the functionality of the scale is autonomous after initial setup.Up to eight (8) users may create profiles to use a single scale. The scale has an automatic recognition function, where it recognizes the user based on the user’s previous weight and profile. If two users have similar body weight profiles, they will be prompted to identify themselves using their initials at the time of weight measurement (selection by tapping the appropriate side of the scale).The complementary interface with the Fitbit website allows the user to view their body weight and body fat trend data over time.
2016-10-21
Aria 2 Wi-Fi Smart Scale - The Aria 2 Wireless Smart Scale is a body analyzer that measures body weight and uses bioelectrical impedance analysis (BIA) technology to estimate body fat percentage in generally healthy individuals 13 years of age or older. It is intended for home use only.
2017-10-25
Aria 2 Wi-Fi Smart Scale - The Aria 2 Wireless Smart Scale is a body analyzer that measures body weight and uses bioelectrical impedance analysis (BIA) technology to estimate body fat percentage in generally healthy individuals 13 years of age or older. It is intended for home use only.
2017-10-25
Aria - The ARIA WiFi Smart Scale uses the Bioelectrical Impedance Analysis (BIA) technique to measure body fat composition by sending a low, safe electrical current throughout the body (“foot-to-foot”). The current passes through muscle tissue with lower resistance than through fat tissue. The resistance in fat tissue is termed “bioelectrical impedance” and is the principle of operation for the ARIA scale measurement. The ARIA scale displays the measurement results to the user on a large display that is backlit and easy to read from the standing position. Measurement results include body weight (lb, kg, stone) and body fat (percentage). The scale stores up to 16 readings. The scale is battery operated (4-AA batteries). Prior to use, the user creates a confidential profile on the Fitbit website (which is only available to the user unless affirmatively shared by the user with other users). The scale has an added functionality of wirelessly transmitting the readings to the user’s profile for trending. The user profile is stored locally on the scale, so that the functionality of the scale is autonomous after initial setup.Up to eight (8) users may create profiles to use a single scale. The scale has an automatic recognition function, where it recognizes the user based on the user’s previous weight and profile. If two users have similar body weight profiles, they will be prompted to identify themselves using their initials at the time of weight measurement (selection by tapping the appropriate side of the scale).The complementary interface with the Fitbit website allows the user to view their body weight and body fat trend data over time.
2016-10-21