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510(k) Data Aggregation

    K Number
    K052586
    Device Name
    A & I PEDIATRIC WHEELCHAIRS, MODELS RWAL2006-12, LT3207-12. A & I BARIATRIC WHEELCHAIRS, MODEL NO. WCDE2611P, WCDE2811P
    Date Cleared
    2005-12-09

    (80 days)

    Product Code
    Regulation Number
    890.3850
    Why did this record match?
    Applicant Name (Manufacturer) :

    TAIWAN AN I CO.,LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The A&I Pediatric Wheelchairs are intended to provide mobility to persons, primarily children, who may be limited to a sitting position. The A&I Bariatric Wheelchairs are intended to provide mobility to persons, primarily larger adults, who may be limited to a sitting position.
    Device Description
    Not Found
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    K Number
    K010094
    Device Name
    A & I WHEELCHAIRS
    Date Cleared
    2001-02-15

    (35 days)

    Product Code
    Regulation Number
    890.3850
    Why did this record match?
    Applicant Name (Manufacturer) :

    TAIWAN AN I CO.,LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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