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510(k) Data Aggregation

    K Number
    K233877
    Device Name
    XT Series Power Wheelchair (XT2), XT Series Power Wheelchair (XT4)
    Manufacturer
    Date Cleared
    2024-03-04

    (88 days)

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

    Magic Mobility

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The XT2 power wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position who have the capability of operating a power wheelchair. The XT4 power wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position who have the capability of operating a power wheelchair.
    Device Description
    The XT Series Power Wheelchair has two configurations: XT2 and XT4. They are designed for everyday use for both indoor and outdoor environments including care facilities and private residences. The subject device is intended to provide mobility to persons who are restricted or limited to a sitting position. The XT Series Power Wheelchairs are battery powered, electric motor driven devices that can be used on both indoor and outdoor surfaces (i.e., concrete, asphalt, indoor flooring such as carpet, gravel, grass, and bark/woodchips). The XT Series Power Wheelchair offers two basic seating options: MPS and Rehab. The MPS option is more static and does not allow for additional aftermarket cushions. The Rehab option is more adjustable to adhere to recommendations from the user's physician or physical therapist.
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    K Number
    K213090
    Device Name
    Frontier Series Power Wheelchairs
    Manufacturer
    Date Cleared
    2021-11-19

    (56 days)

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

    Magic Mobility

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Frontier Series Power Wheelchairs are battery-operated devices with wheels that are intended for medical purposes to provide mobility to persons restricted to a sitting position who have the capability of operating a power wheelchair.
    Device Description
    The Frontier Series Power Wheelchairs have four configurations: V4 RWD, V4 FWD, V6, and C73. The Frontier Series Power Wheelchairs are designed for everyday use for both indoor and outdoor environments including care facilities and private residences. The subject devices are intended to provide mobility to persons who are restricted or limited to a sitting position. The Frontier Series Power Wheelchairs are battery powered, electric motor driven devices that can be used on both indoor and outdoor surfaces (i.e., concrete, asphalt, indoor flooring such as carpet, gravel, grass, and bark/woodchips).
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    K Number
    K211574
    Device Name
    Extreme X8
    Manufacturer
    Date Cleared
    2021-07-09

    (49 days)

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

    Magic Mobility

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Extreme X8 Power Wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position who have the capability of operating a power wheelchair.
    Device Description
    The Extreme X8 Power Wheelchair is designed for everyday use for both indoor and outdoor environments including care facilities and private residences. The subject device is intended to provide mobility to persons who are restricted or limited to a sitting position. The Extreme X8 Power Wheelchair is a battery powered, electric motor driven device that can be used on both indoor and outdoor surfaces (i.e., concrete, asphalt, indoor flooring such as carpet, gravel, grass, and bark/woodchips).The Extreme X8 Power Wheelchair offers two basic seating options: MPS and Rehab. The MPS option is more static and does not allow for additional aftermarket cushions. The Rehab option is more adjustable to adhere to recommendations from the user's physician or physical therapist.
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    K Number
    K203083
    Device Name
    Magic 360 Power Wheelchair
    Manufacturer
    Date Cleared
    2021-03-17

    (155 days)

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

    Magic Mobility

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Magic 360 Power Wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position who have the capability of operating a power wheelchair.
    Device Description
    The Magic 360 Power Wheelchair is designed for everyday use for both indoor and outdoor environments including care facilities and private residences. The subject device is intended to provide mobility to persons that are restricted or limited to a sitting position. The Magic 360 Power Wheelchair is a battery powered, electric motor driven device that can be used on both indoor and outdoor surfaces (i.e. concrete, asphalt, indoor flooring, gravel, grass, and bark). The subject device has two seat options: MPS and rehab. The rehab seat option has more built-in adjustments (i.e., width and depth adjustments) and allows for aftermarket cushions. All the wheelchairs include the same power seating options including lift, tilt, recline, and leg elevation to ensure the user to find a position that is comfortable. The Magic 360 Power Wheelchair includes the following accessories: - Extra spreader bar - Slide in table - Lights - Luggage rack - Accessory charger ● - Posture belt - Roho cushion - Jay cushion - MPS push rail - MPS peg push handle - Scooter stopper ● - Retractable docking pin - Fold forward kit Please note, the fold forward kit is an accessory which allows the user to fold the wheelchair and put the wheelchair in a car. To fold the wheelchair the user pulls the red release handle located at the back of the Magic 360 Power Wheelchair. To unfold the wheelchair the user pulls the frame back into place using the armrests.
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