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510(k) Data Aggregation

    K Number
    K240120
    Device Name
    Merlexi Craft Bariatric series of manual wheelchairs
    Manufacturer
    Turbo Wheelchair Co., Inc.
    Date Cleared
    2024-07-05

    (171 days)

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

    Turbo Wheelchair Co., Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Merlexi Craft Bariatric series of manual wheelchairs are intended for use to empower physically challenged persons by providing a means of mobility. This includes temporary and permanent conditions for which manual wheelchairs are generally prescribed for use. In particular, the Merlexi Craft Bariatric wheelchairs are intended for users up to 425 pounds. They are not for MRI environment use.
    Device Description
    Not Found
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    K Number
    K032731
    Device Name
    MERLEXI CRAFT SERIES OF MANUAL (MECHANICAL) WHEELCHAIRS
    Manufacturer
    TURBO WHEELCHAIR CO., INC.
    Date Cleared
    2003-10-30

    (57 days)

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

    TURBO WHEELCHAIR CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    for the indications for use stated in the enclosure
    Device Description
    Not Found
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