Aria FB201B2

GUDID 00810351028895

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.

FITBIT, INC.

Bioelectrical body composition analyser

• Primary Device ID: 00810351028895
• NIH Device Record Key: 7901ee43-69a4-4b5f-9b2b-2789806cb980
• Commercial Distribution Discontinuation: 2018-10-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Aria
• Version Model Number: FB201B2
• Catalog Number: FB201B2
• Company DUNS: 829454672
• Company Name: FITBIT, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +1(877)623-4997
• Email: support@fitbit.com
• Phone: +1(877)623-4997
• Email: support@fitbit.com

Operating and Storage Conditions

• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810351028895 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133872

FDA Product Code

• MNW: Analyzer, Body Composition

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2018-10-31
• Device Publish Date: 2016-10-21

Devices Manufactured by FITBIT, INC.

• 00810038852720 - Fitbit Irregular Rhythm Notifications: 2022-05-03 The Fitbit Irregular Rhythm Notifications is a software-only mobile medical application that is intended to be used with compati
• 00810038851983 - Fitbit ECG App: 2020-10-15 The Fitbit ECG App is a software-only mobile medical application intended for use with Fitbit wrist-wearable devices to create,
• 00810351028895 - Aria: 2018-10-31The 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.
• 00810351028895 - Aria: 2018-10-31 The ARIA WiFi Smart Scale uses the Bioelectrical Impedance Analysis (BIA) technique to measure body fat composition by sending a
• 00816137020800 - Aria 2 Wi-Fi Smart Scale: 2018-03-29 The Aria 2 Wireless Smart Scale is a body analyzer that measures body weight and uses bioelectrical impedance analysis (BIA) tec
• 00816137020831 - Aria 2 Wi-Fi Smart Scale: 2018-03-29 The Aria 2 Wireless Smart Scale is a body analyzer that measures body weight and uses bioelectrical impedance analysis (BIA) tec