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510(k) Data Aggregation

    K Number
    K220213
    Device Name
    Empulse R90
    Manufacturer
    Sunrise Medical (US) LLC
    Date Cleared
    2022-03-30

    (63 days)

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

    Sunrise Medical (US) LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Empulse R90 is intended to be used to provide power assistance to manual wheelchair users. It is designed to augment the manual propulsion provided by the user, reducing the effort required by the user to propel the wheelchair.
    Device Description
    The Empulse R90 is an auxiliary power module to provide augmented power to manual wheelchair users. The device utilizes a single electric drive wheel to provide the augmented power. The device mounts to a camber tube (rigid wheelchair) or a compressible axle (folding wheelchair) to provide the assisted power. On-board sensors, including an inclinometer, accelerometer and motor current sensing to determine when the user wishes to move forward and if the system is on an incline or decline. The removable Lithium lon battery pack is easily switched out to an alternate battery pack if additional range is required. The battery can also be removed if the user wishes to reduce the overall weight. The actuator is used to automatically engage and disengage the locking latch as well as compress the pre-load traction spring when the user wishes to disconnect the EMPULSE R90 from the wheelchair. In the extended position, the actuator allows the pre-load spring to provide sufficient pre-load to the drive wheel to ensure sufficient traction.
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    K Number
    K172384
    Device Name
    Quickie(r) Q700-UP M
    Manufacturer
    Sunrise Medical (US) LLC
    Date Cleared
    2018-01-16

    (161 days)

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

    Sunrise Medical (US) LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sunrise Medical Quickie® Q700-UP M power wheelchairs are battery operated devices, that are indicated for medical purposes to provide mobility and repositioning of the user, including a stand-up feature.
    Device Description
    This submission covers the Q700-UP M which includes the following new components to the Sunrise Medical Quickie® Pulse 6SC: - 1. Requires a knee block that was a previous option - 2. Adds a stand-up actuator (PG Drives Technology) to power the stand-up feature - 3. Requires a different version of the power center leg-rest to support the patient's weight when standing. - 4. Adds a CSXM power seating control module (PG Drives Technology) to control the seating during standing - 5. A caster / suspension lock-out system to stabilize the base when stand-up is actuated. The Sunrise Medical Quickie® Q700-UP M power wheelchairs are battery operated devices, that are indicated for medical purposes to provide mobility and repositioning of the user, including a stand-up feature. The Sunrise Medical Quickie® Q700-UP M power wheelchairs provide seating and standing function for patients who cannot stand on their own.
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    K Number
    K160031
    Device Name
    Quickie Pulse (Models 6BC, 6SC, 6CC, 5BC, 5CC, 6MPC) and Zippie ZM-310 (Models BC, SC)
    Manufacturer
    SUNRISE MEDICAL (US) LLC
    Date Cleared
    2016-07-14

    (189 days)

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

    SUNRISE MEDICAL (US) LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Quickie® and Zippie® power wheelchairs are battery-operated devices with wheels that are intended for medical purposes to provide mobility to persons restricted to a sitting position. The Zippie power wheelchairs are specifically for people who are slightly smaller in stature—including children.
    Device Description
    Quickie and Zippie wheelchairs are battery-powered, user-controlled, electric wheelchairs. All models of these wheelchairs will be offered with an optional wireless pointer control feature. This option entails adding a Bluetooth Mouse Module (BMM)—a small Bluetooth transmitter—mounted to the chair and wired into its control bus. With BMM in place, the wheelchair's controller can then use the pointer-control feature built into the BMM hardware and software. Pointer control can only be activated when the wheelchair is stationary and not actively performing wheelchair functions. The BMM lets users use the chair's joystick, or other input device, to control the pointer functions of Bluetooth-enabled devices (such as personal or tablet computers) while the chair is not in operation. The wireless pointer control feature will be offered on all models of the Quickie Pulse and Zippie ZM-310 series chairs. Technologically, all of these chair designs are identical. Model designations relate to widths and heights of their seats and various components: such as seating, wheels, and other options available. Quickie Pulse chairs are sized to fit medium to large size individuals Zippie ZM-310 chairs fit individuals of smaller stature—including children. These chairs, along with the BMM, are meant for use in healthcare facilities, in the home, outdoors, and other places of individual activity for the disabled.
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    K Number
    K142457
    Device Name
    Quickie, Zippie
    Manufacturer
    Sunrise Medical (US) LLC
    Date Cleared
    2014-12-18

    (107 days)

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

    Sunrise Medical (US) LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Quickie® and Zippie® power wheelchairs are battery-operated devices with wheels that are intended for medical purposes to provide mobility to persons restricted to a sitting position. The Zippie® power wheelchairs are specifically for people who are slightly smaller in stature-including children.
    Device Description
    The Quickie® and Zippie® power wheelchairs are designed for indoor use at care facilities and private residences. The pediatric variant of the Quickie® Pulse 6, branded the Zippie® ZM-310, is intended to provide a slightly broader range of seating size options for people that are smaller in stature-including children. It varies from the Quickie® Pulse 6 only in having smaller seat options. The Quickie® and Zippie® power wheelchairs are center-wheel-drive battery-powered wheelchairs which will perform optimally on firm even surfaces such as concrete, asphalt and indoor flooring. The wheelchairs have steel and aluminum frame structure which is welded and utilizes standard foams and covers for the seat. The braking system can be initiated by either automatic or electric means. The brakes are automatically on except when the wheelchair is turned on and the joystick has been moved away from the neutral position. When the joystick is released or moved back to neutral, the brakes engage again. If the electrical brake system fails, the brakes will default to the closed, or "brakes on" position, thereby stopping the wheelchair. Actuators allow the seating to be adjusted to suit the user and activity. A control system (i.e. controller and joystick) controls motor, brakes, drive wheel and batteries. This product is appropriate for use by any individual who has the ability to drive a power wheelchair without having to utilize the services of an attendant. In addition, the controls give the optional capability for attendant control. The optional drive controller R-net system provides further features. The controller is fully programmable.
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    K Number
    K133855
    Device Name
    BREEZY ELEGANCE
    Manufacturer
    SUNRISE MEDICAL (US) LLC
    Date Cleared
    2014-01-31

    (43 days)

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

    SUNRISE MEDICAL (US) LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Breezy Elegance Folding Manual Wheelchairs are manually operated devices with wheels that are intended for medical purposes to provide mobility to persons restricted to a sitting position.
    Device Description
    The product offering consists of a standard folding aluminum wheelchair. (Standard in the sense that it is not built to a specific order, rather it will be built to inventory.) The wheelchairs are - User-propelled, as such, chair has 24" wheels with attached handrims - Foldable (using a cross-brace design) for easier transport and stowage The device comprises - Cross-braced folding frame - Quick-release Axle - Large rear wheels with handrims for self-propulsion - Smaller front wheels on casters for stability - Padded seat sling material designed to support a seat cushion and to fold when the wheelchair frame is folded - An upholstered backrest designed to fold when the wheelchair frame is folded, pre-set angle to 8 - Push handles at top of backrest to allow attendant to aid mobility of rider - Swing-away armrests and swing-in/swing-out legrests (with footplates) Available Options Elevating legrest Anti-tip Tubes
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