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510(k) Data Aggregation

    K Number
    K243783
    Device Name
    Walking rehabilitation training electric wheelchair (ZW518)
    Manufacturer
    Shenzhen Zuowei Technology Co., Ltd.
    Date Cleared
    2025-03-12

    (93 days)

    Product Code
    IPL
    Regulation Number
    890.3900
    Why did this record match?
    Product Code :

    IPL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Walking rehabilitation training electric wheelchair is to provide indoor mobility, including stand-up feature, to persons limited to a seating position that are capable of operating a powered wheelchair.
    Device Description
    Walking rehabilitation training electric wheelchair (ZW518)
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    K Number
    K202728
    Device Name
    Action Trackchair Hawk
    Manufacturer
    Action Manufacturing Inc.
    Date Cleared
    2022-02-10

    (510 days)

    Product Code
    IPL
    Regulation Number
    890.3900
    Why did this record match?
    Product Code :

    IPL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Action Trackchair all-terrain power wheelchair provides mobility to individuals who need a power wheelchair and are capable of operating a powered wheelchair.
    Device Description
    Action Trackchair Hawk
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    K Number
    K203761
    Device Name
    ParaMotion
    Manufacturer
    PowerBaseTec GmbH
    Date Cleared
    2022-01-21

    (394 days)

    Product Code
    IPL
    Regulation Number
    890.3900
    Why did this record match?
    Product Code :

    IPL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - Any individual who needs a power wheelchair and can not stand up on their own such as people with paraplegia, spina bifida, cerebral paresis, multiple sclerosis, muscular dystrophy and polio - any individual to take part in sports activities requiring an upright position
    Device Description
    The ParaMotion is an all-terrain electric wheelchair with an integrated standing function. All functions are controlled via the joystick control panel. Strong electric motors on the front wheels with wide terrain tires ensure safe handling, and obstacles are overcome easily. The ParaMotion is steered by targeted control of the drive wheels with appropriate operation of the joystick. The dual rear wheel is freely mounted on a steering shaft and thus has a 360° turning radius. This ensures excellent manoeuvrability of the ParaMotion. The joystick control panel also manages the standing function to the driving functions. An electric motor ensures adjustment of the seat from the horizontal position to the upright position. At the same time, the angle of the backrest and the hinges of the leg support are adjusted so that the operator assumes an upright position in the end position. Thanks to the infinitely variable linear motor, any position between the seated position and the standing position can be assumed. All control functions are carried out by means of an R-Net wheelchair control. Thanks to the easy programmability of the R-Net system, the driving functions can be adapted to suit the user's needs.
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    K Number
    K191334
    Device Name
    Tek RMD (TEK ROBOTIC MOBILIZATION DEVICE) TEKRMD02, TEKRMD03, TEKRMD04, TEKRMD04, TEKRMD05, TEKRMD06, TEKRMD07, TEKRMD08
    Manufacturer
    MATIA Robotics (US) Inc
    Date Cleared
    2020-05-29

    (378 days)

    Product Code
    IPL
    Regulation Number
    890.3900
    Why did this record match?
    Product Code :

    IPL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Tek RMD (Robotic Mobilization Device) is an electric lift and mobile stander and brings the user from a seated position to a passive standing position.
    Device Description
    Tek RMD (TEK ROBOTIC MOBILIZATION DEVICE) Models: TEKRMD02, TEKRMD03, TEKRMD04, TEKRMD04, TEKRMD06, TEKRMD06, TEKRMD07, TEKRMD08
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    K Number
    K190682
    Device Name
    Explorer Mini
    Manufacturer
    Permobil AB
    Date Cleared
    2020-02-27

    (346 days)

    Product Code
    IPL
    Regulation Number
    890.3900
    Why did this record match?
    Product Code :

    IPL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Explorer Mini is a pediatric powered wheelchair with the intention to provide mobility to pediatric users weighing up to 35 pounds and maximum length of up to 39 inches tall, between 12-36 months of age, who position themselves in a sitting position in the wheelchair and have the capacity to operate a joy stick hand control.
    Device Description
    The Explorer Mini includes a base to which the wheels and casters are attached. An adjustable height, vertical column is attached to the base. The driver control (joystick) is integrated at the top of the column and the seating system is attached to the column. The Explorer Mini speed and direction are controlled via a control system comprising a power module and joystick. The Explorer Mini has the appearance of a "ride on toy" and weighs between 60% and 90% less than typical power chairs available to this population today. Explorer Mini seat is configured with a permanent 360degree support assembly positioned around the upper torso for added user safety and stability. This assembly supports both sitting and standing. An adjustable-position saddle shaped seat is used for sitting. The saddle shape allows for 'straddle' standing or alternately the seat can be removed to open the area for full active standing. The 360degree support assembly adjusts to accommodate and support standing while driving. The Explorer Mini is powered by two 5 Amp. batteries providing an approximate driving range up to 4.6 miles. The base provides the propulsion which is derived from two (left and right) front mounted gear-motor wheel assemblies supported by two rear mounted 360degree swiveling casters. Also incorporated in the base are the batteries and control module. When the user activates the joystick, the controller receives a signal to move the device in the direction the joystick is pointed. Simultaneously, the controller directs the gear-motors to respond appropriately. When the user releases the joystick, the chair decelerates to a stop. The inherent gear ratio holds the device in place like a park brake.
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    K Number
    K191874
    Device Name
    F5 Corpus VS
    Manufacturer
    Permobil AB
    Date Cleared
    2019-10-25

    (105 days)

    Product Code
    IPL, ITI
    Regulation Number
    890.3900
    Why did this record match?
    Product Code :

    IPL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The F5 Corpus VS powered wheelchair is to provide indoor mobility, including stand-up feature, to persons limited to a seating position that are capable of operating a powered wheelchair.
    Device Description
    F5 Corpus VS Powered Wheelchair is battery powered, front wheel motor driven and is controlled by the R-net 120 amp controller. The user interface is a joystick. The F5 Corpus VS is powered by two 12VDC, Group M24, approximate driving range on fully charged batteries is up to 25km (15.5 miles), depending on use and the terrain the chair is driven on. The chair frame is a steel construction and includes two front drive units (motor, gear and brake), two batteries and two rear pivoting casters. Depending on the user's needs, the joystick motor control is mounted to the left or right armrest. When the user activates the joystick, the controller receives a signal to release the brakes. With the brakes released, the chair is allowed to move in the joystick is actuated. When the user releases the joystick, the chair slows to a stop and the brakes are automatically re-engaged. The solenoid electromechanical brakes allow the user to stop by letting go of the joystick. F5 Corpus VS will enable the user to stand up, completely or partially, to facilitate reaching, working eye to eye with colleagues. The standing sequence is controlled by the joystick and gives the user the possibility to come to a standing position. The seating, chest support and knee stop stabilize the user during the stand-up or sitdown operation.
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    K Number
    K182257
    Device Name
    UPnRIDE
    Manufacturer
    UPnRIDE Robotics Ltd.
    Date Cleared
    2019-09-12

    (387 days)

    Product Code
    IPL
    Regulation Number
    890.3900
    Why did this record match?
    Product Code :

    IPL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The UPnRIDE™ stand-up power wheelchair is intended for medical purposes to provide mobility to persons restricted to a sitting position. The product changes position from Sitting to Standing and Standing to Sitting but also any position in between. The product provides indoor and outdoor mobility.
    Device Description
    The UPnRIDE™ device enables disabled and elderly individuals to be mobile in a sitting or standing position indoors and outdoors. The device design is based on the following principles: 1. Using motorized jointed braces and harnessing to safely support the user while sitting, shifting to standing, standing and returning to sitting - 2. Center of gravity (COG) is maintained substantially at the center of the device in all positions, thus maximizing stability and safety. - 3. Balancing the platform which supports the user so that the user always remains vertical even on skewed surfaces. - 4. Implementing an operation and safety algorithms to minimize risks and hazards to the user, even beyond the provisions of standard wheelchairs. The product is comprised of the following modules: - Driving module: a motorized driving chassis that 1. includes two front motorized wheels, two high capacity Li-Ion batteries 21.6VDC / 29.7Ah and a steel frame which is installed as a chassis for the device's components. - Inertial Measurement Unit ("IMU") for measuring 2. ground slopes (pitch and roll) and user's tilt angles (pitch and roll). - Standing and sitting module: a motor-based lifting 3. mechanism for shifting between standing and sitting positions. - 4. Balancing module: a platform that balances the user while sitting or standing, relative to earth. - 5. User interface module: a unit through which the user controls the UPnRIDE™. This module has an "R-NET" controller that contains a Joystick, commanding buttons and a display for viewing indications and status and a switching box for controlling the various modes of operation. - Actuator drivers: five units that control the lifting 6. motors. - 7. Main Controller: a unit which reads all sensors and user inputs, performs the balancing and safety algorithms, and controls all the chairs function.
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    K Number
    K191376
    Device Name
    Modular Power Standing System
    Manufacturer
    Motion Concepts
    Date Cleared
    2019-08-13

    (82 days)

    Product Code
    IPL
    Regulation Number
    890.3900
    Why did this record match?
    Product Code :

    IPL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Modular Power Standing System is appropriate for use by individuals who drive a power wheelchair and cannot stand up on their own. The Modular Power Standing System allows such users to change position including from seating to standing, standing to seating, or any position in between. The device is appropriate for indoor and outdoor use. Motion Concepts makes no claims as to the therapeutic effectiveness of the products. Our only claims relate to the ability of the products to provide safe and reliable powered repositioning on the equipment onto which they are installed.
    Device Description
    The Modular Power Standing System (MPSS) is a seating system which is added to a wheelchair powerbase to provide four basic functions: power stand-up, power tilt, power recline including shear reduction, and power elevate. It can be operated in private residences, chronic care facilities, indoor and outdoors. Note the MPSS in itself does not include any wheelchair base components such as wheelchair frame, drive controls, wheels, brakes, batteries, suspension etc. The Stand function is used to orient the user in an upright position. The mechanism consists of linkages driven by linear actuators. The system includes both a knee support to help stabilize the user in the standing position. The Tilt function is used to change the seating inclination angle of user. The mechanisms consist of linkages driven by linear actuators. The range of tilt is 0° to 45°. The Recline function causes the position of the occupant's back to change by changing the position of the backrest with respect to the seat pan. The Shear Reduction works in conjunction with Recline to reduce the shear movement between the user and the backrest. The mechanisms consist of linkages driven by linear actuators. The range of Recline is 90° to 178°. The Elevating seat module allows the user to elevate the entire seat. The mechanisms consist of linkages driven by linear actuators. The range of elevation is 6.5 inches. The maximum occupant weight for the system is 250 lb. The Modular Power Standing System is assembled using primarily laser-cut steel parts, steel tube, machined aluminum, and mounting hardware. The various power positioning modules may be activated via two options: using switches or through the powerbase manufacturer supplied joystick. Safety features include a drive lock-out and reduced drive mode which are activated when any of the power functions are activated beyond pre-set limits. The system also includes front castor locks to provide additional front stability when in stand mode. Electrical components are maximum 24 volts and include current limiting within the seat control box. Stability of the Modular Power Standing System was tested on the powerbase selected for this application. These tests were conducted to ensure the safety of the power wheelchair was not compromised by the addition of the Modular Power Standing System.
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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?
    Product Code :

    IPL

    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
    K163451
    Device Name
    Action Trackstander models TR1816, TR1820, TR2016, and TR2020
    Manufacturer
    Action Manufacturing Inc.
    Date Cleared
    2018-01-12

    (400 days)

    Product Code
    IPL
    Regulation Number
    890.3900
    Why did this record match?
    Product Code :

    IPL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Action Trackstander all-terrain power wheelchair with the integrated stand-up position function provides mobility to individuals who need a power wheelchair, that are capable of operating a powered wheelchair and cannot stand up on their own. The Action Trackstander does not require a doctor's prescription.
    Device Description
    Action Trackstander models Tr1816. Tr1820. Tr2016. and Tr2020
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