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510(k) Data Aggregation

    K Number
    K070501
    Device Name
    RUIKE 3421 POWERED WHEELCHAIR
    Manufacturer
    SHANGHAI RUIKE SPORTS GOODS CO., LTD.
    Date Cleared
    2007-03-22

    (29 days)

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

    SHANGHAI RUIKE SPORTS GOODS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ruike 3421 powered wheelchair is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position.
    Device Description
    The Ruike 3421 powered wheelchair is an indoor/outdoor powered wheelchair that is battery operated. The design of this wheelchair is basically similar to other powered wheelchairs that are already on the market. But the Ruike 3421 is kind oh a new class of lightweight powered wheelchair. By providing a powered wheelchair that breaks down into two manageable components (seat frame, body frame with motors and battery pack), a user can have a more practical alternative when traveling long distances by bus, train, etc.
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    K Number
    K062646
    Device Name
    RUIKE, MODEL 3411
    Manufacturer
    SHANGHAI RUIKE SPORTS GOODS CO., LTD.
    Date Cleared
    2007-02-05

    (154 days)

    Product Code
    INI, 89I
    Regulation Number
    890.3800
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHANGHAI RUIKE SPORTS GOODS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ruike 3411 scooter is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position.
    Device Description
    The Ruike 3411 scooter is an indoor/outdoor transportation vehicles which is battery operated. The movement of the scooter is controlled by a tiller handle and a thumb operated potentiometer throttle control lever to engage and disengage the scooter motion in both the forward and reverse directions.
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    K Number
    K062645
    Device Name
    RUIKE, MODEL 3431
    Manufacturer
    SHANGHAI RUIKE SPORTS GOODS CO., LTD.
    Date Cleared
    2006-12-19

    (104 days)

    Product Code
    INI, 89I
    Regulation Number
    890.3800
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHANGHAI RUIKE SPORTS GOODS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ruike 3431 scooter is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position.
    Device Description
    The Ruike 3431 scooter is an indoor/outdoor transportation vehicles which is battery operated. The movement of the scooter is controlled by a tiller handle and a thumb operated potentiometer throttle control lever to engage and disengage the scooter motion in both the forward and reverse directions.
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    K Number
    K062676
    Device Name
    RUIKE, MODEL 3331
    Manufacturer
    SHANGHAI RUIKE SPORTS GOODS CO., LTD.
    Date Cleared
    2006-12-14

    (97 days)

    Product Code
    INI, 89I
    Regulation Number
    890.3800
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHANGHAI RUIKE SPORTS GOODS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ruike 3331 scooter is intended for an indoor/outdoor scooter that provides transportation for disabled or elderly persons limited to a seated position. The Ruike 3331 scooter is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position.
    Device Description
    The Ruike 3331 scooter is an indoor/outdoor transportation vehicles which is battery operated. The movement of the scooter is controlled by a tiller handle and a thumb operated potentiometer throttle control lever to engage and disengage the scooter motion in both the forward and reverse directions.
    Ask a Question

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