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510(k) Data Aggregation

    K Number
    K252502
    Device Name
    Folding Mobility Scooter (KD101)
    Manufacturer
    Nanjing Kangni Smart Technology Co.,Ltd.
    Date Cleared
    2025-10-06

    (59 days)

    Product Code
    INI
    Regulation Number
    890.3800
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    K231428
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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 Folding mobility scooter, has a base with metal frame, two front wheels, two rear wheels, a seat, a LED Display, electric motor, electromagnetic brake, 1 rechargeable Lithium Battery pack (with 2 batteries) with an off-board charger. The movement of the scooter is controlled by the rider who operates the control lever. 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 device can be folded up from front to back.

    The device has 2 options, with a faucet adjustment or without a faucet adjustment.

    AI/ML Overview

    N/A

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