BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    SupaChair Powered Wheelchair

    K Number: K173315 · Decision Feb 13, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    125
    Registration Numbers
    125
    Same Product Code
    580
    Applicant Total
    4
    Review Days
    117

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    Basic Information

    Device Name
    SupaChair Powered Wheelchair
    K Number
    K173315
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.3860
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Eurogreen International, Inc.
    Date Received
    October 19, 2017
    Decision Date
    February 13, 2018
    Product Code
    ITI
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    ITI Wheelchair, Powered

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    Other Clearances by Eurogreen International, Inc.

    K Number Device Name
    K182631 SupaScoota Motorized vehicle - Spartan (Sumo)/ Spartan SP (Sumo SP)
    K173313 SupaChair Powered Wheelchair: COMBI 18, COMBI 18SP, COMBI 20, COMBI 20SP
    K143557 SupaScoota Motorized vehicle