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510(k) Data Aggregation

    K Number
    K242358
    Device Name
    Powered wheelchair (mobility robot) (M4, M4U)
    Manufacturer
    Date Cleared
    2025-04-03

    (238 days)

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

    XSTO CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Powered wheelchair (mobility robot) is a motor driven transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
    Device Description
    Not Found
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