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510(k) Data Aggregation

    K Number
    K250533
    Device Name
    Magnesium alloy scooter (RS100)
    Manufacturer
    Taizhou Reach Technology Co., Ltd
    Date Cleared
    2025-05-14

    (79 days)

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

    Taizhou Reach Technology 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
    RS100 is a Mobility Scooter which provides mobility to a disabled or elderly person limited to a seated position. The Mobility Scooter is classified in the Class B and the maximum loading weight is 125kg. The scooter is a battery powered three-wheeled vehicle. It consists Lithium-ion battery with an off-board battery charger, frame, controllers, motor, seat, back support, arm supports, control panel (including speed knob, battery gauge, power key switch, horn button, throttle control lever, charger port) two rear wheels, one front wheel, foot support. For convenience of transportation and reduction of possible damage, the battery and arm supports can be dismantled and separately packaged. Users can also easily assemble these parts without use of the tools.
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