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510(k) Data Aggregation

    K Number
    K242628
    Device Name
    Scooter (PS30)
    Manufacturer
    Lichtmega Technology Co., Ltd.
    Date Cleared
    2024-12-20

    (108 days)

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

    Lichtmega 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
    This scooter is a motor driven, indoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position. The PS30 Scooter has a base with aluminum allov frame, two rear wheels, two anti-tip wheels, a seat, a tiller console, an electric motor, an electromagnetic brake, 1 rechargeable lithium Battery with an off-board charger. The movement of the scooter is controlled by the rider who operates the throttle lever, speed control dial and handle on 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. The Scooter only can be operated on the flat road. The scooter is provided in four colors - cherry Red, Neptune Blue, Sunburst Orange, Frozen Grey Mat, for the outer shell of wheels and consoler panel.
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    K Number
    K241460
    Device Name
    Manual Wheelchair
    Manufacturer
    Lichtmega Technology CO., Ltd.
    Date Cleared
    2024-07-11

    (49 days)

    Product Code
    IOR
    Regulation Number
    890.3850
    Why did this record match?
    Applicant Name (Manufacturer) :

    Lichtmega Technology CO., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Manual Wheelchair is to provide mobility to persons limited to a sitting position.
    Device Description
    MW18 manual wheelchair is a mechanical which is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. It can be folded for transport by bring the two sides together. The manual wheelchair incorporates a foldable frame, a seat, two footrests and four wheels. The larger rear wheels have push-rims of slightly smaller diameter projecting just beyond the user to manoeuvre the chair by pushing them on without requiring them to grasp the tyres. The manual wheelchairs have brakes that bear on the tyres of there are two push handles at the upper rear of the frame to allow for manual propulsion by a second person, e.g. caregiver. The wheelchair can support users of up to 120kg. Main Components: Main frame, back upholstery, seat upholstery, handgrip, armrest, front wheel, hand rim, crossbar, footrest, skirt guard, brake, anti-tipper (optional) The device can be operated indoors, or outdoors on dry, level surfaces composed of concrete, blacktop, or asphalt under normal driving conditions.
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