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510(k) Data Aggregation

    K Number
    K252588

    Validate with FDA (Live)

    Date Cleared
    2025-12-04

    (111 days)

    Product Code
    Regulation Number
    890.3800
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    It is 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 Mobility Scooter (T5) is a motor driven, indoor and outdoor transportation vehicle. It has an overall dimension of 1240mm610mm875mm and a steel frame. It features a foldable tiller, removable battery pack, and disassembles for transport. It has 2 rear wheels, a ground clearance of 20 mm, and a maximum loading capacity of 150kg on level ground. The minimum turn radius is 2175mm, and it is powered by a 24V 350W motor with rear-wheel drive. Braking is handled by an electromagnetic brake. It uses a Li-ion Battery 25.6Vdc 15Ah with a 29.4V/2A charger. The maximum speed is 7.92 km/h, and it can handle a maximum slope of 6°. The travel distance is 18.5 km, with a brake time of less than 1 second and a brake distance of ≤1.3m (horizontal-forward at max speed). The total mass is 54 kg. It is intended for indoor use and restricted outdoor use on pavements or paved footpaths only. It does not have a remote control. The folding mechanism includes a foldable column and a removable basket. The front and rear tire diameters are 9 inches.

    AI/ML Overview

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