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510(k) Data Aggregation

    K Number
    K123076
    Device Name
    PROFTHAND MECHANICAL WHEELCHAIR
    Date Cleared
    2013-08-09

    (312 days)

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

    HARMONY HILL INTERNATIONAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Profhand pedal wheelchair is manually operated multifunctional wheelchairs designed for indoor/outdoor use and intended to provide mobility to persons that have the capability of operating a mechanical wheelchair.
    Device Description
    Profhand pedal wheelchair is manually driven, lightweight, performance type of wheelchairs that have been designed and developed to be used in both indoor and outdoor environments, and to transport one (1) person at a time. The Chassis and pedaling mechanism are made form a aluminum alloy. Wheels are of a spoke and hub design using metal components and rubber tires, while the casters are of a semi-solid polymer base design. The seat cushion and back are made from flame retardant Nylon and/or Polyester fabric. The main operation of Profhand pedal wheelchair is as the following description (Note: This main operation can only be done under the instruction and permission of physician, so it is classified as a prescription device): Put a suitable seat cushion on the wheelchair seat. Put your foot into the pedal and attach the foot strap to stabilize foot. When riding use both legs to pedal for forward movement. To stop use the brake mounted in the control lever. For parking or getting on/off the wheelchair lock the brakes. In addition to the main operation as above mentioned, the Profhand pedal wheelchair also provide the handle bars in rear side of the chair to let healthcare person help moving the person who is seated on the wheelchair as the other general mechanical wheelchair.
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