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510(k) Data Aggregation

    K Number
    K133872
    Device Name
    ARIA WIFI SMART SCALE
    Manufacturer
    FITBIT, INC.
    Date Cleared
    2014-06-02

    (164 days)

    Product Code
    MNW
    Regulation Number
    870.2770
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K121971
    Why did this record match?
    Device Name :

    ARIA WIFI SMART SCALE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ARIA WiFi 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 10 years of age or older. It is intended for home use only.

    Device Description

    ARIA is a body weight scale and a body fat analyzer that operates by using a low, safe, battery-generated electrical current through the body (using a bioelectrical impedance analysis technique) to provide body fat and body weight information. After the user registers their scale, the scale automatically recognizes the subject based on body weight and body fat readings. ARIA contains a WiFi module (802.11 module) that allows it to connect to the Internet in the user's home. The module provides a complementary interface to the Fitbit website. Body weight and body fat measurements are independent of internet communication after initial product registration.

    The ARIA scale automatically measures body weight and body fat composition. The scale recognizes the user based on previous weight readings, and can accept up to eight (8) different users. The 16 most recent readings are kept in memory on the scale and readings are also transmitted to the user's optional fitbit.com personal account for trending. If users have similar weight, the proper identity can be selected by tapping the scale.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the Fitbit ARIA WiFi Smart Scale, based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    The acceptance criteria for the ARIA WiFi Smart Scale are established not through explicit numerical thresholds but by demonstrating substantial equivalence to a predicate device (Withings Smart Body Scale K121971) and showing that its body fat measurements are not statistically different from the predicate, with variation within an acceptable range.

    Feature/MetricAcceptance Criteria (Implied from Predicate/Study)Reported Device Performance
    Substantial EquivalenceDemonstrates equivalence in technology, intended use, classification, product code, indication for use, device description, analysis method, operating parameters, number of electrodes, power source, IP connectivity, and measured parameters to the predicate device (Withings WBS01 Smart Body Scale K121971).The ARIA WiFi Smart Scale is listed as substantially equivalent to the Withings Smart Body Scale (K121971) across all listed features. Differences noted (e.g., age range, specific power source type, minor IP connectivity details) are presented as not impacting substantial equivalence.
    Body Fat MeasurementBody fat composition (%) measurements should not be statistically different (p>0.05) from the predicate device, and body fat measurements should vary by 0.05) and body fat measurements varied by
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