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510(k) Data Aggregation

    K Number
    K021165
    Device Name
    NEW HEIGHTS ELECTRIC ELEVATING POWER WHEELCHAIR MODEL NO. 08 02 SERIES
    Manufacturer
    BROMAC ASSISTIVE TECHNOLOGY
    Date Cleared
    2002-07-01

    (81 days)

    Product Code
    IPL
    Regulation Number
    890.3900
    Why did this record match?
    Applicant Name (Manufacturer) :

    BROMAC ASSISTIVE TECHNOLOGY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    These wheelchairs have been designed as general purpose utility wheelchairs, to be used in, and for, the user's day to day living and transportation. They function as any standard power wheelchair does, however they are also designed to allow the user to easily and temporarily elevate the seating system to raise the user to a height slightly greater than that of an average person standing, or any height in between, allowing the user access to high shelves and cabinets, and other things which would be out of reach when seated in a standard wheelchair.
    Device Description
    New Heights Electric Electric Elevating Power Wheelchair Model No. 08 02 series
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    K Number
    K012345
    Device Name
    NEW HEIGHTS ELECTRIC ELEVATING MANUAL WHEELCHAIR
    Manufacturer
    BROMAC ASSISTIVE TECHNOLOGY
    Date Cleared
    2001-10-03

    (71 days)

    Product Code
    IPL
    Regulation Number
    890.3900
    Why did this record match?
    Applicant Name (Manufacturer) :

    BROMAC ASSISTIVE TECHNOLOGY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This wheelchair is designed as a general purpose utility wheelchair, to be used in, and for, the users day to day living and transportation. It functions as any standard manual wheelchair does, however it is also designed to allow the user to easily and temporarily elevate the seating system to raise the user to a height slightly greater than that of an average able bodied person standing, or any height in between, allowing the user to access high shelves and cabinets, and other things which would be out of reach when seated in a standard wheelchair.
    Device Description
    Not Found
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