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510(k) Data Aggregation

    K Number
    K251616
    Device Name
    Clear Miracle
    Manufacturer
    ODS Co., Ltd.
    Date Cleared
    2025-07-22

    (56 days)

    Product Code
    NXC
    Regulation Number
    872.5470
    Why did this record match?
    Applicant Name (Manufacturer) :

    ODS Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K190737
    Device Name
    Solax Electric Scooter (Models: S204311M, S204161, S204143)
    Manufacturer
    Dongguan Prestige Sporting Goods Co., Ltd.
    Date Cleared
    2021-05-10

    (780 days)

    Product Code
    INI
    Regulation Number
    890.3800
    Why did this record match?
    Applicant Name (Manufacturer) :

    Dongguan Prestige Sporting Goods Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    It 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 Solax Electric Scooter (Models: S204311M, S204161, S204143) is an indoor/outdoor electric scooter that is intended to be used by individuals that are able to walk, but suffer from mobility limitations. It has the following main components: two 6 inch solid front tires, two 7 inch solid rear tires, two anti-tip tires, control panel, steering handles, seat folding lever, backrest, arm rest, seat, steering column, seat frame, front/ rear covers, folding release lever, angle adjustment lever, height adjustment lock, carry handle, an off-board charger and aluminum alloy made frame, It is powered by two Li-ion DC rechargeable batteries with 18 km (on level surface) which maximum speed up to 6 km/hr. The movement of the scooter is controlled by the steering handles and control panel. The device is installed with an electromagnetic brake that will engage automatically when the scooter is not in use and the brake cannot be used manually.
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    K Number
    K200978
    Device Name
    Electric Wheelchair (Model: S7110)
    Manufacturer
    Dongguan Prestige Sporting Goods Co., Ltd.
    Date Cleared
    2021-04-16

    (368 days)

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

    Dongguan Prestige Sporting Goods Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Electric wheelchair (Model: S7110) is a motor driven, indoor transportation vehicle with the intended use to provide mobility to a disabled or elderly limited to a seated position.
    Device Description
    Not Found
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    K Number
    K202632
    Device Name
    Electric wheelchair (S7204/S7205)
    Manufacturer
    Dongguan Prestige Sporting Goods Co., Ltd.
    Date Cleared
    2021-04-08

    (209 days)

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

    Dongguan Prestige Sporting Goods Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is a power wheelchair intended to provide mobility to persons restricted to a sitting position.
    Device Description
    The Electric wheelchair (Model S7204, S7205) is a power wheelchair intended to provide mobility to persons restricted to a sitting position. The Electric wheelchair (Model S7204, S7205) is about 136 kg weight capacity. It is basic conventional rear wheels drive, rigid frame vehicle that are battery powered. It consists primarily of a welded-aluminum frames, sealed transaxle motors drive system, electromagnetic braking system, electric motor controller and Li-ion batteries with an off-board battery charger. It is powered by rechargeable batteries with 45 km which maximum speed up to 7 km/h. The controller with a joystick attaches to either armrest and allows the rider to control the movement and velocity of the powered wheelchair. When the joystick is released. the electromagnetic brake will be actuated and the power wheelchair is slow to stop. It consists of three parts which are chair part, control part and drive part. Overall it mainly has a basic aluminum alloy frame, two front wheels, two rear wheels, two anti-tip wheels, a seat, a footrest, an controller, an electric motor, an electromagnetic brake and a Lithium battery with an off-board charger. The result of "tiltover" tests performed laterally (12° ), posteriorly (16° ), and anteriorly (12° ) with a user of maximum allowable weight in the least stable configuration: No overturn performed laterally, posteriorly, and anteriorly with 136kg in the least stable configuration.
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    K Number
    K191897
    Device Name
    Solax Electric Scooter (Models: S3023, S3024, S3025, S3026)
    Manufacturer
    Dongguan Prestige Sporting Goods Co., Ltd.
    Date Cleared
    2021-02-10

    (575 days)

    Product Code
    INI
    Regulation Number
    890.3800
    Why did this record match?
    Applicant Name (Manufacturer) :

    Dongguan Prestige Sporting Goods Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    It 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
    Not Found
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    K Number
    K200857
    Device Name
    Electric wheelchair (Model: S7012)
    Manufacturer
    Dongguan Prestige Sporting Goods Co., Ltd.
    Date Cleared
    2020-12-17

    (260 days)

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

    Dongguan Prestige Sporting Goods Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Electric wheelchair is a motor driven transportation vehicle with the intended use to provide mobility to a disabled or elderly limited to a seated position.
    Device Description
    The Electric wheelchair (Model S7012) is to provide mobility to adults, limited to a seated position that have capability to operate a few simple controls and the ability to control a powered wheelchair. The device and accessories (remote controller, AC power wire, charger, and battery) are reusable. The Electric wheelchair (Model S7012) is about 125 kg weight capacity and size is about 840mm x 640mm x 930mm if unfold and about 700mm x 640mm x 370mm if fold. It is basic conventional rear wheels drive, rigid frame vehicle that are battery powered. It consists primarily of a foldable welded-aluminum frames, sealed transaxle motors drive system, electromagnetic braking system, electric motor controller and Li-ion batteries with an off-board battery charger. It has some components as two front wheels, two rear wheels, two anti-tip wheels, a seat, a footrest, and has a remote for folding/unfolding the device. Its basic function is powered by rechargeable batteries with 15 km which has a maximum speed up to 6 km/h. The controller with a joystick attaches to either armrest and velocity of the powered wheelchair. When the joystick is released, the electromagnetic brake will be actuated and the power wheelchair is slow to stop. The joystick can move up and down, left and right. There is a speed button to adjust the speed, and the speed indicator can display the speed. In addition, there is a remote control to control the folding and unfolding of the device. And no any new features of the device.
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    K Number
    K131302
    Device Name
    SOLAX
    Manufacturer
    DONGGUAN PRESTIGE SPORTING GOODS CO., LTD.
    Date Cleared
    2013-11-26

    (203 days)

    Product Code
    INI
    Regulation Number
    890.3800
    Why did this record match?
    Applicant Name (Manufacturer) :

    DONGGUAN PRESTIGE SPORTING GOODS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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 ZIPPY scooter consists of a retractable platform which connects the two front wheels and two rear wheels, an adjustable tiller, a lead acid battery with an off-board charger, a motor/electromagnetic brake assembly, a electric motor controller and a seat /backrest set. It can be retracted for transport in a car trunk. The patient uses the tiller handle/handlebar for steering and a thumb operated potentiometer throttle control lever located at the top of the tiller to engage and disengage the scooter motion in both the forward and reverse directions. When the throttle control lever is released, the electromagnetic brake will be actuated and the scooter is slow to stop.
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    K Number
    K070501
    Device Name
    RUIKE 3421 POWERED WHEELCHAIR
    Manufacturer
    SHANGHAI RUIKE SPORTS GOODS CO., LTD.
    Date Cleared
    2007-03-22

    (29 days)

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

    SHANGHAI RUIKE SPORTS GOODS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ruike 3421 powered wheelchair is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position.
    Device Description
    The Ruike 3421 powered wheelchair is an indoor/outdoor powered wheelchair that is battery operated. The design of this wheelchair is basically similar to other powered wheelchairs that are already on the market. But the Ruike 3421 is kind oh a new class of lightweight powered wheelchair. By providing a powered wheelchair that breaks down into two manageable components (seat frame, body frame with motors and battery pack), a user can have a more practical alternative when traveling long distances by bus, train, etc.
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    K Number
    K062646
    Device Name
    RUIKE, MODEL 3411
    Manufacturer
    SHANGHAI RUIKE SPORTS GOODS CO., LTD.
    Date Cleared
    2007-02-05

    (154 days)

    Product Code
    INI, 89I
    Regulation Number
    890.3800
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHANGHAI RUIKE SPORTS GOODS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ruike 3411 scooter is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position.
    Device Description
    The Ruike 3411 scooter is an indoor/outdoor transportation vehicles which is battery operated. The movement of the scooter is controlled by a tiller handle and a thumb operated potentiometer throttle control lever to engage and disengage the scooter motion in both the forward and reverse directions.
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    K Number
    K062645
    Device Name
    RUIKE, MODEL 3431
    Manufacturer
    SHANGHAI RUIKE SPORTS GOODS CO., LTD.
    Date Cleared
    2006-12-19

    (104 days)

    Product Code
    INI, 89I
    Regulation Number
    890.3800
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHANGHAI RUIKE SPORTS GOODS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ruike 3431 scooter is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position.
    Device Description
    The Ruike 3431 scooter is an indoor/outdoor transportation vehicles which is battery operated. The movement of the scooter is controlled by a tiller handle and a thumb operated potentiometer throttle control lever to engage and disengage the scooter motion in both the forward and reverse directions.
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