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

    NEW HEIGHTS ELECTRIC ELEVATING MANUAL WHEELCHAIR

    K Number: K012345 · Decision Oct 3, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    65
    Applicant Total
    2
    Review Days
    71

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    Basic Information

    Device Name
    NEW HEIGHTS ELECTRIC ELEVATING MANUAL WHEELCHAIR
    K Number
    K012345
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.3900
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Bromac Assistive Technology
    Date Received
    July 24, 2001
    Decision Date
    October 3, 2001
    Product Code
    IPL
    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
    IPL Wheelchair, Standup

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    Other Clearances by Bromac Assistive Technology

    K Number Device Name
    K021165 NEW HEIGHTS ELECTRIC ELEVATING POWER WHEELCHAIR MODEL NO. 08 02 SERIES