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510(k) Data Aggregation

    K Number
    K241529
    Device Name
    Powered Wheelchair (NXN20-209)
    Date Cleared
    2024-11-22

    (176 days)

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

    Zhejiang Nysin Medical Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The device is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
    Device Description
    The subject device, Powered Wheelchair, mainly powered by battery, motivated by DC motor, driven by user controlling joystick and adjusting speed. The Powered Wheelchairs consist of two foldable armrests, a backrest, a seat cushion, a safety belt, a foldable frame, two rear driving wheels with hub motor/electromagnetic brake assemblies, two pivoting casters, two Li-ion batteries, an off-board battery charger, a control panel, and an electric motor controller. The NXN20-209 Powered Wheelchair is intended to provide mobility to a disabled or elderly person limited to a seated position. The Powered Wheelchair has 7 inch front wheel and 12 inch rear tire. The motor of electric wheelchair is DC24V 200W; the battery is 24V 12AH, Li-ion battery; the charger is 24V/3A. Max. loading can not be over than 110Kgs. Max. distance of travel on the fully charged battery is 16.5 km and Max. speed forward is 6km/h. The braking time is about 2s, and the braking distance is less than or equal to 1.76m.
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    K Number
    K241603
    Device Name
    Powered Wheelchair (NXN20-208, NXN20-211)
    Date Cleared
    2024-11-20

    (169 days)

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

    Zhejiang Nysin Medical Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The device is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
    Device Description
    The subject device, Powered Wheelchair, mainly powered by battery, motivated by DC motor, driven by user controlling joystick and adjusting speed. The Powered Wheelchairs consist of two foldable armrests, a backrest, a seat cushion, a safety belt, a foldable frame, two rear driving wheels with hub motor/electromagnetic brake assemblies, two pivoting casters, two Li-ion batteries, an off-board battery charger, a control panel, and an electric motor controller. The NXN20-208 and NXN20-211 Powered Wheelchair is intended to provide mobility to a disabled or elderly person limited to a seated position. The Powered Wheelchair has 7 inch front wheel and 11 inch rear tire. The motor of electric wheelchair is DC24V 200W; the battery is 24V 12AH, Li-ion battery; the charger is 24V/3A. Max. loading can not be over than 110Kgs. Max. distance of travel on the fully charged battery is 16 km and Max. speed forward is 6km/h. The braking time is about 2s, and the braking distance is <=1.77m.
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    K Number
    K241379
    Device Name
    Powered Wheelchair (NXN20-205, NXN20-205M)
    Date Cleared
    2024-09-16

    (124 days)

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

    Zhejiang Nysin Medical Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The device is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
    Device Description
    The subject device, Powered Wheelchair, mainly powered by battery, motivated by DC motor, driven by user controlling joystick and adjusting speed. The Powered Wheelchairs consist of two foldable armrests, a backrest, a seat cushion, a safety belt, a foldable frame, two rear driving wheels with hub motor/electromagnetic brake assemblies, two pivoting casters, two Li-ion batteries, an off-board battery charger, a control panel, and an electric motor controller. The NXN20-205 and NXN20-205M Powered Wheelchair is intended to provide mobility to a disabled or elderly person limited to a seated position. The Powered Wheelchair has 7 inch front wheel and 12 inch rear tire. The motor of electric wheelchair is DC24V 200W; the battery is 24V 12AH, Li-ion battery; the charger is 24V/3A. Max. loading can not be over than 110Kgs. Max. distance of travel on the fully charged battery is 16km and Max. speed forward is 5.5km/h. The braking time is about 2s, and the braking distance is ≤790m.
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