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510(k) Data Aggregation

    K Number
    K083303
    Device Name
    LANDLEX, MODEL: 402X
    Manufacturer
    BESTEAM TECHNOLOGY INC.
    Date Cleared
    2009-01-26

    (77 days)

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

    BESTEAM TECHNOLOGY INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To provide mobility to disabled or elderly persons limited to a seated position
    Device Description
    The LANDLEX 402x 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
    K081980
    Device Name
    KYMCO FORU, MODEL EQ35
    Manufacturer
    BESTEAM TECHNOLOGY INC.
    Date Cleared
    2008-08-04

    (24 days)

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

    BESTEAM TECHNOLOGY INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    KYMCO ForU EQ35 scooter is intended for an indoor/outdoor scooter that provides transportation for disabled or elderly persons limited to a seated position. To provide mobility to disabled or elderly persons limited to a seated position.
    Device Description
    The KYMCO ForU EQ35 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
    K063196
    Device Name
    LANDLEX, MODEL S403X
    Manufacturer
    BESTEAM TECHNOLOGY INC.
    Date Cleared
    2007-01-23

    (95 days)

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

    BESTEAM TECHNOLOGY INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LANDLEX S403X 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 LANDLEX S403X 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
    K060042
    Device Name
    LANDLEX, MODEL P100X
    Manufacturer
    BESTEAM TECHNOLOGY INC.
    Date Cleared
    2006-02-14

    (39 days)

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

    BESTEAM TECHNOLOGY INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LANDLEX P100X 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 LANDLEX P100X 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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