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510(k) Data Aggregation

    K Number
    K955547
    Device Name
    CHIPS STANDUP WHEELCHAIR
    Date Cleared
    1996-09-20

    (290 days)

    Product Code
    Regulation Number
    890.3860
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTERNATIONAL HEALTHCARE SOLUTIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The I.H.S. Chips Power Standup Wheelchair helps promote mobility for its intended user, who typically is limited in full use of lower extremities. These limitations will usually be of long or permanent duration and caused by numerous medical conditions ranging from spinal cord injuries, broken bones, stroke, as well as numerous other disabilities. The subject device, through a safe and effective lifting motion, helps promote well-being by enabling the user at will to safely and securely change his posture from a sitting position to fully upright, allowing the bodies natural articulation to accomplish this.
    Device Description
    Standup Wheelchair. The main product components include a steel tubular welded frame which supports a sitting surface. Both the seat and the back support are made of a durable nylon material. In addition, the frame incorporates adjustable and removable armrests providing support for the user occupant and removable to facilitate transfer into and out of the wheelchair. Both leg rests and foot rests are designed in a unitized construction to structurally support the users body weight while standing. The foot rest assembly is designed to swing away to facilitate entry and exit to the Standup chair and the assembly is removable to facilitate transportation of the above described features are typical in predicate devices. Power is supplied to the device by incorporating two 12 volt wet or gel cell batteries providing a 24 volt system. This in turn supplies power to two rear mounted direct drive motors, both incorporating electromechanical automatic brakes. The motors in turn provides power to a sealed gear box which transfers power to the rear wheels. The Penny & Giles PG 8 Programmable control system provides reliable, precise control and conforms to the latest International Standards.
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    K Number
    K955548
    Device Name
    CHIPS POWERED WHEELCHAIR
    Date Cleared
    1996-09-20

    (290 days)

    Product Code
    Regulation Number
    890.3860
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTERNATIONAL HEALTHCARE SOLUTIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The specific intended use of the power wheelchair, which is the subject device, is identical to pre-existing or predicate devices. I.H.S. CHIPS POWER CHAIR helps promote mobility, both indoors, for the intended user commonly lacking full use of lower extremities. This limited use could be of short or long duration and caused by numerous medical conditions, ranging from spinal cord injuries to temporary broken bones in a lower extremity.
    Device Description
    Powered Wheelchair. Our subject device provides mobility by incorporating a joy stick type controller which sends power to electric gear motors, which in turn are directly driving two rear wheels which propel the device. The controller on the subject device, similar to predicate devices, incorporates safety features such as, speed control, sensitivity control, battery life indicator and power on and off indicator light. The main product components include a steel tubular welded frame which supports a sitting surface. Both the seat and the back support are made of a durable nylon material. In addition, the frame incorporates adjustable and removable armrests, providing support for the user, and is removable to facilitate transfer into and out of the wheelchair. Both leg rests and foot rests are designed to be fully adjustable to accommodate a variety of anatomical differences. All leg rests and foot rests assembly are designed to swing away to facilitate entry and exit to the power chair and are removable to facilitate transportation of the device. Power is supplied to the device by incorporating two 12 volt wet or gel cell batteries providing a 24 volt system. This in turn supplies power to two rear mounted direct drive motors, both incorporating electromechanical automatic brakes. The motors in turn provide power to a sealed gear box which transfers power to the rear wheels. The fully programmable control system provides reliable, precise control and conforms to the latest International Standards. It has plenty of drive to cope with curbs or hill climbing by continually monitoring motor voltage and current. It readily maintains constant speed over demanding uneven terrain and prevents unwanted rolling on slopes. It handles currents from 20 Amps per channel, is fully programmable, incorporates true charge battery level indicator, has user speed and response controls, and a horn to alert others. It incorporates sophisticated diagnostics to facilitate repair and provides speed stability on slopes for safety. It incorporates hand tremor dampening for users who have poor motor control.
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