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510(k) Data Aggregation

    K Number
    K242975
    Device Name
    Mobility Scooter (Model X-01, X-02)
    Manufacturer
    Wuyi Aichi Industry & Trade Co., Ltd.
    Date Cleared
    2025-05-07

    (223 days)

    Product Code
    INI
    Regulation Number
    890.3800
    Why did this record match?
    Applicant Name (Manufacturer) :

    **Wuyi Aichi Industry **& Trade Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended / indications for use for the FreeStyle Libre 3 system are as follows: * The FreeStyle Libre 3 Flash Glucose Monitoring System is a continuous glucose monitoring (CGM) device with real-time alarms capability indicated for the management of diabetes in persons aged 4 years and older. * It is intended to replace blood glucose testing for diabetes treatment decisions unless otherwise indicated. * The System performs a scan every minute to measure interstitial fluid glucose concentrations.
    Device Description
    Google Wifi point and AC2200 router with Ethernet port and USB-C port
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