BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    HP-3, BATTETRY OPERATED, FONT WHEEL DRIVE, POWER WHEELCHAIR

    K Number: K011745 · Decision Aug 30, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    125
    Registration Numbers
    125
    Same Product Code
    580
    Applicant Total
    4
    Review Days
    85

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    Basic Information

    Device Name
    HP-3, BATTETRY OPERATED, FONT WHEEL DRIVE, POWER WHEELCHAIR
    K Number
    K011745
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    890.3860
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Transworld Mobility Distribution, LLC
    Date Received
    June 6, 2001
    Decision Date
    August 30, 2001
    Product Code
    ITI
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    ITI Wheelchair, Powered

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    Other Clearances by Transworld Mobility Distribution, LLC

    K Number Device Name
    K020002 MODEL P-33, BATTERY OPERATED, THREE WHEEL, POWER SCOOTER , MODEL P-33
    K020001 PF-3, BATTERY OPERATED, FOUR WHEEL, POWER SCOOTER, MODEL PF-3
    K011744 HP-5, BATTERY OPERATED, REAR WHEEL DRIVE, POWER WHEELCHAIR