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510(k) Data Aggregation

    K Number
    K991090
    Device Name
    PEACHTREE PROPORTIONAL HEAD CONTROL UNIT (PHC-3)
    Manufacturer
    DYNAMIC SYSTEMS, INC.
    Date Cleared
    1999-09-24

    (176 days)

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

    DYNAMIC SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Peachtree Proportional Head Control model PHC-3 is intended to offer persons restricted to a seated position the ability to operate a powered wheelchair by three different methods. The first is a non-contact, fully proportional head movement commanded driving control. The next is controlled by a series of blowing and inhaling into a straw. This allows for four way directional control of the wheelchair. The last driving method uses a combination of the two previous drive controls. The user would tilt their had laterally to move the wheelchair left or right and blow or inhale into the straw to control forward/reverse direction/speed. At current the PHC-3 has only been made to be compatible with Invacare's MKIV series of electronics and Dynamic Controls DX series of electronics.
    Device Description
    Not Found
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    K Number
    K972147
    Device Name
    PEACHTREE PROPORTIONAL HEAD CONTROL UNIT (PHC-2)
    Manufacturer
    DYNAMIC SYSTEMS, INC.
    Date Cleared
    1997-08-25

    (77 days)

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

    DYNAMIC SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PHC-2 is intended to provide mobility control to persons restricted to a seated position while operating a power-drive wheelchair. The Peachtree Proportional Head Control Unit is non-contact, fully proportional, head movement commanded driving control intended to provide mobility control to persons restricted to a seated position while operating a variety of available power-drive wheelchairs.
    Device Description
    The PHC-2 consists of a headrest pad containing a control unit which provides invisible contact between the user and the wheelchair. The control unit is a remote, electronic, two dimensional head position sensing device that utilizes a low level, high frequency electrical field to provide contact between the user and the wheelchair. The PHC-2 control unit does not require physical attachments to the user. The user simply tilts his or her head to provide control commands to the wheelchair. The PHC-2 has two operational modes: control and drive, the user enters the various modes and functions by gently tapping the head rest a designated number of times. On power up, the unit is always in control mode which includes the following functions: stop, recline, ECU, and drive. The stop function results in no activity, recline allows the user to recline the back of the wheelchair with head motions, and the ECU function controls an environmental control unit, if available. The second level is drive mode which includes: stop, reverse, forward low, and forward high. Within the drive modes the user can accelerate, brake, spin, and turn by utilizing non-contact head movements.
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