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510(k) Data Aggregation

    K Number
    K202728
    Device Name
    Action Trackchair Hawk
    Manufacturer
    Action Manufacturing Inc.
    Date Cleared
    2022-02-10

    (510 days)

    Product Code
    IPL
    Regulation Number
    890.3900
    Why did this record match?
    Applicant Name (Manufacturer) :

    Action Manufacturing Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Action Trackchair all-terrain power wheelchair provides mobility to individuals who need a power wheelchair and are capable of operating a powered wheelchair.
    Device Description
    Action Trackchair Hawk
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    K Number
    K181908
    Device Name
    Action Trackchair
    Manufacturer
    Action Manufacturing Inc.
    Date Cleared
    2018-12-03

    (139 days)

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

    Action Manufacturing Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Action Trackchair all-terrain power wheelchair provides mobility to individuals who need a power wheelchair, that are capable of operating a powered wheelchair and are limited to a seated position. The Action Trackchair does not require a doctor's prescription.
    Device Description
    Not Found
    Ask a Question
    K Number
    K163451
    Device Name
    Action Trackstander models TR1816, TR1820, TR2016, and TR2020
    Manufacturer
    Action Manufacturing Inc.
    Date Cleared
    2018-01-12

    (400 days)

    Product Code
    IPL
    Regulation Number
    890.3900
    Why did this record match?
    Applicant Name (Manufacturer) :

    Action Manufacturing Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Action Trackstander all-terrain power wheelchair with the integrated stand-up position function provides mobility to individuals who need a power wheelchair, that are capable of operating a powered wheelchair and cannot stand up on their own. The Action Trackstander does not require a doctor's prescription.
    Device Description
    Action Trackstander models Tr1816. Tr1820. Tr2016. and Tr2020
    Ask a Question

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