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510(k) Data Aggregation

    K Number
    K182631
    Device Name
    SupaScoota Motorized vehicle - Spartan (Sumo)/ Spartan SP (Sumo SP)
    Manufacturer
    Eurogreen International Inc.
    Date Cleared
    2019-09-19

    (360 days)

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

    Eurogreen International Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    As a motorized portable electric vehicle for indoor or outside use by persons with medical conditions requiring assistance.
    Device Description
    A battery operated lightweight portable mobility device designed for personal travel indoors and limited outdoor use and available in 4 wheel configurations. It is used in a sitting position and operated by a hand controlled throttle located on the handle bars. Braking is automatically controlled when releasing the throttle by the electronic controller and magnetic motor brake. The product is supplied ready to use with a battery and charger and it can be disassembled and folded for transport. Steel frame, battery cycle life of Sealed Lead Acid battery is 400 charging times, 24V15ah Lithium battery is 1000 charging times, 24V12ah Lithium battery is 800 charging times.
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    K Number
    K173313
    Device Name
    SupaChair Powered Wheelchair: COMBI 18, COMBI 18SP, COMBI 20, COMBI 20SP
    Manufacturer
    Eurogreen International Inc.
    Date Cleared
    2018-02-13

    (117 days)

    Product Code
    ITI
    Regulation Number
    890.3860
    Why did this record match?
    Applicant Name (Manufacturer) :

    Eurogreen International Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is a power wheelchair intended to provide mobility to persons restricted to a sitting position.
    Device Description
    The device is a power wheelchair. Common Name: Powered Wheelchair Trade Name: "SupaChair" Powered Wheelchair Classification Name: Powered Wheelchair Regulation Number: 890.3860 Product Code: ITI Device Class: Class 2 Model: COMBI 18/ COMBI 20/ COMBI 18SP/ COMBI 20SP
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    K Number
    K173315
    Device Name
    SupaChair Powered Wheelchair
    Manufacturer
    Eurogreen International Inc.
    Date Cleared
    2018-02-13

    (117 days)

    Product Code
    ITI
    Regulation Number
    890.3860
    Why did this record match?
    Applicant Name (Manufacturer) :

    Eurogreen International Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is a power wheelchair intended to provide mobility to persons restricted to a sitting position
    Device Description
    The device is a powered wheelchair intended to provide mobility to persons restricted to a sitting position. It is available in three models: SAFARI, SAFARI SPORT, and MINI. It is battery operated and has brake systems.
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