BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Aria

    DI: 00898628002038 · Model: FB201W · FITBIT, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Aria
    Primary DI
    00898628002038
    Version / Model
    FB201W
    Catalog Number
    FB201W
    Company Name
    FITBIT, INC.
    Labeler DUNS
    829454672
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-10-21
    Public Version
    5
    Public Version Date
    2018-10-31
    Public Version Status
    Update
    Public Device Record Key
    eb8e3db8-a302-47e5-a95c-186e66eb5ee5
    Distribution End Date
    2018-10-31

    Device Description

    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.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    MNW Analyzer, Body Composition

    GMDN Terms

    Code Name
    36022 Bioelectrical body composition analyser

    Identifiers

    Type ID
    Primary 00898628002038

    Customer Contacts

    Phone
    +1(877)623-4997
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K133872 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    -22 – 140 Degrees Fahrenheit
    Type
    Storage Environment Humidity
    Temperature Range
    15 – 90 Percent (%) Relative Humidity
    Type
    Handling Environment Temperature
    Temperature Range
    41 – 104 Degrees Fahrenheit
    Type
    Handling Environment Humidity
    Temperature Range
    15 – 93 Percent (%) Relative Humidity