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510(k) Data Aggregation

    K Number
    K072153
    Device Name
    QUICKIE QX MANUAL FOLDING WHEELCHAIR
    Manufacturer
    SUNRISE MEDICAL, INC.
    Date Cleared
    2007-09-10

    (38 days)

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

    SUNRISE MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sunrise Medical Quickie QX Manual Folding Mechanical Wheelchair's intended use is to provide mobility to persons restricted to a sitting position. The Quickie QX Manual Folding Wheelchair is a mechanical wheelchair that is a manually operated device with wheels that is intended for medical purposes which provides an optional means of mobility for physically challenged people. The mechanical wheelchair is indicated for physically challenged individuals and can provide a means of mobility.
    Device Description
    The Quickie QX Manual Folding Wheelchair is a mechanical wheelchair that is a manually operated device with wheels.
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    K Number
    K062701
    Device Name
    QUICKIE RHAPSODY, MWD SERIES II POWER WHEELCHAIR
    Manufacturer
    SUNRISE MEDICAL, INC.
    Date Cleared
    2006-09-25

    (14 days)

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

    SUNRISE MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Quickie MWD Series II Power Wheelchair's intended use is to empower physically challenged individual by providing a means of mobility.
    Device Description
    Not Found
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    K Number
    K031289
    Device Name
    QUICKIE FREESTYLE POWER WHEELCHAIR, MODEL G-424
    Manufacturer
    SUNRISE MEDICAL, INC.
    Date Cleared
    2003-05-09

    (16 days)

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

    SUNRISE MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Center Drive Power Wheelchair's intended use is to empower physically challenged individuals by providing a means of mobility.
    Device Description
    Not Found
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    K Number
    K010917
    Device Name
    POWER TILT AND RECLINE SYSTEM
    Manufacturer
    SUNRISE MEDICAL, INC.
    Date Cleared
    2001-05-15

    (49 days)

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

    SUNRISE MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K011268
    Device Name
    BREEZY WHEELCHAIR, MODEL 300
    Manufacturer
    SUNRISE MEDICAL, INC.
    Date Cleared
    2001-05-15

    (19 days)

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

    SUNRISE MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K001491
    Device Name
    QUICKIE 2 POWER ASSIST WHEELCHAIR
    Manufacturer
    SUNRISE MEDICAL, INC.
    Date Cleared
    2000-12-15

    (217 days)

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

    SUNRISE MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K981885
    Device Name
    SUNRISE SCOOTER SERIES, MODEL UNASSIGNED, 3 WHEEL STANDARD MODEL, 3 WHEEL MID RANGE MODEL, 3 WHEEL HIGH END MODEL, 4 WHE
    Manufacturer
    SUNRISE MEDICAL, INC.
    Date Cleared
    1998-11-12

    (167 days)

    Product Code
    INI
    Regulation Number
    890.3800
    Why did this record match?
    Applicant Name (Manufacturer) :

    SUNRISE MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sunrise scooters empower physically challenged persons by providing a means of mobility.
    Device Description
    The Three Wheeled mid Range Scooter is a medium duty, conventional, rear whech drive, rigid frame power Vehicle. The armrests of the sear are adjustable. The seat may be repositioned from from to back and chair height can be adjusted up and down. There are many kinds of accessories that are commonly sold after market. These accessories include canopies, crutch holders, cup holders, baskers etc. Like most scooters, the tiller and throttle controls are the user interface. They transfer the rider's intentions to command the device. When the control is activated, or moved out of neutral position, the motor brake is energized and released, allowing the scooter to move in the appropriate direction. When the activation device is released, the scooter slows to a stop and the motor brake is automatically reengaged. These dynamic "on command" brakes allow the user to stop by letting go of the activation device. If the scooter looses power, the motor brake is automatically engaged and the scooter comes to a stop. To prevent the rider from becoming stranded, the scooter may be pushed. The design incorporates a "free wheel" device motor lock disengagement device. This device allows the drive train to be manually disengaged, enabling the scooter to be pushed. It should be noted that the scooter would not have electronic brakes when in the "free wheel" mode. The controller is microprocessor based and program-able. It is pro-programmed at the manufacturer to meet Sunrise specifications. This controller is currently used on selected models of the Sunrise scooters under K880425. Drive characteristics that are pre set are: forward/reverse acceleration forward speed forward/reverse deceleration reverse speed The controller also has manual reset circuit breakers. These adjustments and features are similar to all standard scooter controllers.
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    K Number
    K981462
    Device Name
    QUICKIE P100 SERIES, QUICKIE P200 SERIES, QUICKIE P300 SERIES, MODELS P100,P110,P120,P190,P190R,P500,P200,P210,P320,P300
    Manufacturer
    SUNRISE MEDICAL, INC.
    Date Cleared
    1998-11-06

    (197 days)

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

    SUNRISE MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sunrise powered wheelchairs empower physically challenged persons by providing a means of mobility.
    Device Description
    The Quickie P190 R (or S525) is a medium duty, conventional, rear wheel drive, and rigid frame power wheelchair. The Quickie P190R Power Wheelchair consists of typical components found on most wheelchairs, such as push handles, armrests, backrest, seat frame, cushion, footrest and casters. Accessories that may be added after market include items such as positioning belts, backpacks, seat pouches, oxygen tank holders, IV poles, etc. As a motorized wheelchair, it also controller, a joystick, a motor, brakes, a drive wheel and 2 batteries. Like most power wheelchairs, the joystick is the user interface. It transfers intentions to command the chair. When the control is activated, or moved out of the center position, the motor brake is energized and released, allowing the chair to move in the direction of the activation. When the activation device (joystick or afternate input device) is released, the chair slows to a stop and the motor brake is automatically re-engaged. These dynamic "on command" brakes allow the user to stop by letting go of the activation device. If the chair loses power, the motor brake is automatically engaged and the chair comes to a stop. To prevent the rider from becoming stranded, the chair may be pushed. The chair incorporates a "free wheel" device motor lock disengagement option. This option allows the drive train to be manually disengaged, enabling the chair to be more easily pushed by an assistant. It should be noted that the chair would not have electronic brakes when in the "free wheel" mode. However, the manual wheel locks (also optional) will still function if engaged.
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    K Number
    K983520
    Device Name
    BREATH CONTROL (BREATH ACTUATOR), SENSITOUCH BREATH CONTROL, HEAD ARRAY (SWITCH HEAD CONTROL), TRI-SWITCH HEAD ARRAY, HD
    Manufacturer
    SUNRISE MEDICAL, INC.
    Date Cleared
    1998-11-06

    (29 days)

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

    SUNRISE MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Alternate input devices are designed to provide those with sever physical disabilities the independence to operate a power wheelchair, a power seating system, and an environmental control unit from a single actuating device.
    Device Description
    Alternate actuators (input devices) are designed to provide those with severe physical disabilities the independence to operate a power wheelchair, a power seating system, and an environmental control unit using a device other than the standard joystick. A variety of alternate input actuators are currently available on the market as many power wheelchair users require some form of input control other than a joystick. In prior submissions, several alternate input devices (specialty controls) and their interface modules were employed in addition to the main wheelchair controller. These included the breath tube interface, which contained a pressure transducer, a single switch scanner module and a display. Other specialty control functions also required independent display boxes and / or displays. However Quickie's new controllers, that are intended to interface with specialty input devices, have incorporated these functions into the Controller/ USCM (Universal Specialty Control Module). This greatly simplifies the wheelchair's configuration as it eliminates the need for additional dedicated interface boxes and displays to be mounted on the chair. As with the devices currently marketed by Quickie, the alternate actuator is used to signal both the speed and direction of the power chair, as well as the selection of various operating modes which are then controlled by the wheelchair controller/USCM. Examples of the various modes that can be controlled are: maximum speed, drive profile (e.g. indoor/outdoor), latched driving, powered seating systems and environmental controls systems. The method of selection for both drive control and mode is dependent upon the type of alternate input actuator. Two basic types of input actuators exist: proportional and switched. Both types are compatible with Quickie's controller/USCM. When using alternate input actuators, the wheelchair controller will enter a sleep state if the actuator has not sent a signal for a specified period of time. This helps to extend the life of the chair batteries, and reduces the likelihood of unintentional movement. The primary change being addressed is the modification of one of the standard connectors used to interface with the Quickie Controllers that have a Universal Specialty Control Unit (USCM). Two of the three connections that were made to the old Multi-mode remain the same. Some devices used a breath tube that activated a pressure transducer that translated the air pressure to electrical signals. This connection remains unchanged. Some devices used a single jack connector to transfer signal. This connection also remains unchanged. The third type of connector employed by the prior Multi-mode device was a DB15 connector. The Controller/ USCM, which replaces the Multi-mode, translates the same signals using a DB9 connector. The DB9 was selected for the Controller/USCM because it has developed across the specialty input device industry as the standard connector. The DB-9 is used by many companies making specialty input devices including Switch-it, Tash, and ASL.
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    K Number
    K983677
    Device Name
    QUICKIE G SERIES, MODEL G-424
    Manufacturer
    SUNRISE MEDICAL, INC.
    Date Cleared
    1998-11-06

    (18 days)

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

    SUNRISE MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sunrise Medical powered wheelchairs empower physically challenged persons by providing a means of mobility. This includes conditions in all ages such as: Arthritis, Amputee, Paraplegic, Cerebral Palsy, Hemiplegic, Tetraplegic (Quadraplegic), Spina Bifida, Head Injury or Trauma, Muscular Dystrophy, Multiple Sclerosis, Polio, Geriatric Conditions, And other immobilizing or debilitating conditions. A wheel chair with Bus Transport option may be used for motor vehicle transportation, with the use of wheelchair tie down and occupant restraint system (WTORS) that meet the requirements of SAE J 2249.
    Device Description
    The G-424 is a mid-wheel drive, moderate duty chair that comes in one basic configuration. It is available with the Pilot controller. The Quickie G-424 Power Wheelchair consists of the same basic components found on the P200, such as a frame with suspension, seat, armrests, footrest, cushion, casters and drive wheels. Accessories include items such as positioning belts, backpacks, seat pouches, oxygen tank holders, IV poles, etc. As motorized wheelchairs, they also contain controllers, joysticks, motors, brakes, drive wheels and batteries. Key changes between the P200 and the G-424 are the replacement of anti-tip wheels with anti-tip casters, change from aluminum to steel frame construction, revised suspension, revised modular seat and use of the Pilot controller from Penny & Giles. Aesthetics have been improved by adding a plastic thermoformed molded cover.
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