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510(k) Data Aggregation

    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?
    Applicant Name (Manufacturer) :

    Motion Concepts

    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
    K182995
    Device Name
    Bariatric Power Positioning System (BPPS)
    Manufacturer
    Motion Concepts
    Date Cleared
    2019-03-08

    (129 days)

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

    Motion Concepts

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bariatric Power Positioning System is appropriate for use by any individual who drives a power wheelchair and who desires or requires a change of position without having to utilize the services of an attendant.
    Device Description
    The Bariatric Power Positioning System (BPPS) is a seating system which is added to a power wheelchair base to provide two basic functions: power tilt, and power recline including shear reduction. Note the BPPS in itself does not include any wheelchair base components such as wheelchair frame, drive train, drive controls, wheels, brakes, batteries, suspension etc. The power Tilt function causes the position of the occupant to change by tilting the whole seat, including the seat pan, backrest, foot supports, and arm supports. The range of tilt is 0° to 50°. The power Recline function causes the position of the occupant's back to 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 latter is accomplished by using a linkage that slides the backrest down on the back posts as the back recline function is also useful for the redistribution of pressure and providing improved body position for certain user activities. The range of Recline is 90° to 150°. The maximum occupant weight for the Bariatric Power Positioning System is up to 400 lb depending on the wheelchair powerbase and seating features selected. The BPPS is assembled using primarily laser-cut steel parts, steel tube, machined aluminum, and mounting hardware. The power positioning modules may be activated via two options: using separate switches or through the wheelchair base manufacturer's joystick control. Safety features include a drive lock-out which prevents the power chair while tilted or reclined beyond a certain pre-set limit. Electrical components are maximum 24 volts and include a current limiter in the relay box. Stability of the Bariatic Power Positioning System was tested on wheelchair powerbases commonly used for power positioning applications. These tests were conducted to ensure the safety of the power wheelchair was not compromised by the addition of the Bariatric Power Positioning System.
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    K Number
    K150574
    Device Name
    Modular Power Positioning System
    Manufacturer
    MOTION CONCEPTS
    Date Cleared
    2015-06-30

    (116 days)

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

    MOTION CONCEPTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Modular Power Positioning system is appropriate for use by any individual who drives a power wheelchair and who desires or requires a change of position without having to utilize the services of an attendant. Needs for position changes include: - All positioning benefits associated with the tilt/recline product: Comfort: As with any individual, able-bodied or disabled, changes in position are necessary to maintain a state of comfort. Positioning: Individuals without adequate upper-body stability can be tilted to allow gravity to hold them in position. Pressure Relief or Reduction: Individuals who wish, from time to time, to redistribute pressure from one area of the body to another, can do so by tilting and/or reclining, By changing the individual's orientation in space, pressures caused by gravity will shift. - Positioning/Versatility: Individuals are able to reach higher elevations in a seated position, increasing their range of motion and accessibility. 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 Positioning System is a seating system which is added to a power wheelchair base to provide three basic functions, power recline including shear reduction, and power elevate (or lift). Note the Modular power positioning system in itself does not include any wheelchair base components such as wheelchair frame, drive train, drive controls, wheels, brakes, batteries, suspension etc. The Tilt unit utilizes a center of gravity shift linkage, which causes the seat frame to shift progressively forward throughout the range of tilt. This enhances the stability since the center of gravity is kept substantially in place while the user is tilting. The Tilt unit may be one of two similarly designed systems, one designed for 50° tilt, and one for 45° tilt which is integrated with the 12 inch linkage style lift. 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 latter is accomplished by using a linkage that slides the backrest down on the back posts as the back reclines. The range of Recline is 90° to 168°. The Elevating seat (or Lift) module allows the user to elevate the entire seat by up to 12 inches. It consists of a standard linkage style mechanism. The maximum occupant weight for the system is up to 300 lb depending on the features of the wheelchair base and system modules selected. The Modular Power Positioning System is assembled using primarily laser-cut steel tube, machined aluminum, and mounting hardware. The various power positioning modules may be activated via two options: using switches or through the wheelchair manufacturer's controller. Switches consist of either push button or toggle style. Safety features include a drive lock-out which prevents the user from driving the power chair while tilted, reclined, or elevated beyond a certain pre-set limit. Electrical components are maximum 24 volts, and include a current limiter in the relay box. Stability of the Modular Power Positioning System was tested on various wheelchairs commonly used for power positioning applications. These tests were conducted to ensure the safety of the power wheelchair was not compromised by the addition of the power positioning system.
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    K Number
    K023426
    Device Name
    TRX VERTICAL POSITIONER
    Manufacturer
    MOTION CONCEPTS
    Date Cleared
    2002-11-21

    (41 days)

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

    MOTION CONCEPTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TRX Vertical Positioner is appropriate for use by any individual who drives a power wheelchair and who desires or requires a change of position without having to utilize the services of an attendant. Needs for position changes include: - All positioning benefits associated with the tilt/recline product - - Comfort As with any individual able-bodied or disabled changes in position are necessary to maintain a state of comfort. - Repositioning Individuals without adequate upper-body stability can be tilted to allow gravity to hold them in position. - Pressure relief Individuals who wish, from time to time, to redistribute pressures from one area of the body to another, can do so by tilting, reclining or vertical positioning. By changing the individual's orientation in space, pressures caused by gravity will shift. - Positioning/Versatility Individuals are able to reach higher elevations, increasing their range of motion and accessibility. The TRX Vertical Positioner is used to add the vertical positioning function to the tilt, recline, and elevating functions already available in with the TRX Power Positioning System defined in K021264. 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. TRX Vertical Positioners are to be installed ONLY by qualified Dealers. The above indications for use are identical to those of the Levo Mobile LCM defined in K963817 to which we are claiming substantial equivalence.
    Device Description
    The TRX Vertical Positioner is used to add the vertical positioning function to the tilt, recline. and elevating functions already available in with the TRX Power Positioning System defined in K021264. The Vertical Positioner functions by coordinating the elevating and reclining motion with an anterior tilt motion to change the user from an upright seated position to a vertical position and back again. The TRX Vertical Positioner is assembled using primarily steel and aluminum, powder coated parts. The vertical positioning is be activated using TRx switches consisting of either push buttons or togale switches, or through the wheelchair joystick. Additional safety features include a drive lock-out which prevents the user from driving the power chair while tilted beyond a pre-set limit of 20° from the vertical or elevated beyond 1/2". The system also includes extensions for the existing front anti-tipper wheels to provide additional front stability, and a lockout for the active track suspension in the vertical positioning mode. Electrical components are a maximum of 24 volts with a fuse between the batteries and the relay box and current limiter built into the relay box. Stability of the TRX Vertical Positioner was tested in our facility to ensure that the safety of the power wheelchair was not compromised by the addition of the system.
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    K Number
    K021264
    Device Name
    TRZ-CG POWER POSITIONING SYSTEM WITH CENTER-OF-GRAVITY SHIFTING POWER TILT, RECLINE, AND POWER ELEVATING SEAT
    Manufacturer
    MOTION CONCEPTS
    Date Cleared
    2002-07-30

    (99 days)

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

    MOTION CONCEPTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TRx-CG is appropriate for use by any individual who drives a power wheelchair and who desires or requires a change of position without having to utilize the services of an attendant. Needs for position changes include: * All positioning benefits associated with the tilt/recline product - > Comfort As with any individual -- able-bodied or disabled -- changes in position are necessary to maintain a state of comfort. > Repositioning Individuals without adequate upper-body stability can be tilted to allow gravity to hold them in position. > Pressure relief Individuals who wish, from time to time, to redistribute pressures from one area of the body to another, can do so by tilting and/or reclining. By changing the individual's orientation in space, pressures caused by gravity will shift. * Positioning/Versatility Individuals are able to reach higher elevations in a seated position, increasing their range of motion and accessibility. 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. TRx-CG Power Positioning Systems are to be installed ONLY by qualified Dealers. The above indications for use are identical to those of the Permobil Tit/Recline/Elevating Seat System to which we are claiming substantial equivalence.
    Device Description
    The TRX-CG Power Positioning System consists of a power tilt unit with optional power recline module, shear reduction module and power elevating seat module. The TRX-CG tilt system utilizes a center-of-gravity shift linkage, which causes the seat frame to shift progressively forward throughout the range of tilt. This enhances stability since the center of gravity is kept substantially in place while the user is tilting. The tilt system may be one of two similarly designed systems, one adapted for front wheel drive chairs and one adapted for rear wheel drive chairs. The tilt range of the power positioning system is 55°. 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 module works in conjunction with recline to reduce the shear movement between the user and the backrest. This is accomplished using a linkage that slides the backrest down on the back posts as the back reclines. The range of recline of the TRX-CG is 168°. The elevating seat module allows the user to elevate the entire system by up to 7 in. It consists of a 24 V ball drive pedestal actuator with a maximum capacity of 500 Ibs and a maximum stroke of 7 in. The maximum occupant weight for the TRX-CG system is up to 400 lbs depending on the features of the base and system modules selected. The minimum seat-to-floor height is 18 ½ in. The TRX-CG is assembled using laser-cut steel parts, steel tube, machined aluminum, delrin blocks and mounting hardware. The power positioning modules may be activated via two options: using TRx switches or through the wheelchair manufacturer's controller. TRx switches consist of either push button switches or toggle switches. Additional safety features include a drive lock-out which prevents the user from driving the power chair while tilted beyond a pre-set limit of 20° from the vertical or elevated beyond ½ in. Tilt limit is also available. Electrical components are a maximum of 24 volts with a fuse between the batteries and the relay box and current limiter built into the relay box. Stability of the TRX-CG was tested in our facility to ensure that the safety of the power wheelchair was not compromised by the addition of the power positioning system.
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    K Number
    K994241
    Device Name
    TRX-CG POWER TILT AND RECLINE SYSTEM
    Manufacturer
    MOTION CONCEPTS
    Date Cleared
    2000-01-13

    (29 days)

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

    MOTION CONCEPTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TRx-CG is appropriate for use by any individual who drives a Quickie G-424, S-525, or an S-626 power wheelchair and who desires or requires a change of position without having to utilize the services of an attendant. Needs for position changes include: - Comfort As with any individual able-bodied or disabled changes in position are necessary to maintain a state of comfort. - Positioning -- Individuals without adequate upper-body stability can be tilted to allow gravity to hold them in position. - Pressure Relief or Reduction Individuals who wish to, from time to time, redistribute pressures from one area of the body to another, can do so by tilting and/or reclining. By changing the individual's orientation in space, pressures caused by gravity will shift.
    Device Description
    TRx-CG Power Tilt and Recline System
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    K Number
    K990544
    Device Name
    TRX-CG POWER TILT AND RECLINE SYSTEM
    Manufacturer
    MOTION CONCEPTS
    Date Cleared
    1999-04-08

    (45 days)

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

    MOTION CONCEPTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TRx-CG system is appropriate for use by any individual who drives an Invacare Storm Power Base wheelchair and who desires or requires a change of position without having to utilize the services of an attendant. Needs for position changes include: Comfort - As with any individual - able-bodied or disabled - changes in position are necessary to maintain a state of comfort. Positioning - Individuals without adequate upper-body stability can be tilted to allow gravity to hold them in position. Pressure Relief or Reduction - Individuals, who wish to, from time to time, redistribute pressure from one area of the body to another, can do so by tilting and/or reclining. By changing the individual's orientation in space, pressures caused by gravity will shift. 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. TRx-CG Tilt and Recline Systems are to be installed ONLY by qualified Dealers. The above indications for use are identical to those of the Tarsys Tilt and Recline System to which we are claiming substantial equivalence.
    Device Description
    TRx-CG Power Tilt and Recline System
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    K Number
    K981837
    Device Name
    TRX-CG CENTER-OF-GRAVITY SHIFTING POWER TILT AND RECLINE SYSTEMS
    Manufacturer
    MOTION CONCEPTS
    Date Cleared
    1998-07-09

    (44 days)

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

    MOTION CONCEPTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Statement of Indications For Use: Otatement of manoutiente for use by any individual who drives a power wheelchair and who desires or requires a change of position without having to utilize the services of an attendant. Needs for position changes include: - 6. Comfort -- As with any individual -- able-bodied -- changes in position are necessary to maintain a state of comfort. - 7. Positioning Individuals without adequate upper-body stability can be tilted to allow gravity to hold them in position. - 8. Pressure Relief or Reduction Individuals who wish to, from time to time, redistribute pressures from one area of the body to another, can do so by tilting and/or reclining. By changing the individual's orientation in space, pressures caused by gravity will shift. 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. The above indications for use are identical to those of the Tarsys Tilt and Recline System to which we are claiming substantial equivalence.
    Device Description
    TRx-CG Power Tilt and Recline System
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    K Number
    K970521
    Device Name
    TRX POWER TILT AND RECLINE SYSTEM
    Manufacturer
    MOTION CONCEPTS
    Date Cleared
    1997-03-31

    (48 days)

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

    MOTION CONCEPTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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