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510(k) Data Aggregation

    K Number
    K253075

    Validate with FDA (Live)

    Device Name
    Mobility scooter (Air Classic); Mobility scooter (Air Traveller); Mobility scooter (Air Traveller2.0)
    Manufacturer
    Suzhou Sweetrich Vehicle Industry Technology Co., Ltd.
    Date Cleared
    2026-01-09

    (108 days)

    Product Code
    INI
    Regulation Number
    890.3800
    Type
    Traditional
    Panel
    Physical Medicine
    Age Range
    All
    Reference & Predicate Devices
    K231472
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K231472

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis 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 Mobility Scooter(Air Classic, Air Traveller, and Air Traveller 2.0) feature a base with an aluminum frame and an ABS body shell. They come equipped with one or two front wheels, two rear wheels, two armrests, a seat, a control panel, direction handles, electrical machinery, an electromagnetic brake, and rechargeable lithium-ion batteries with an off-board charger.The movement of the scooter is controlled by control panel and direction handles.

    The device is installed with an electromagnetic brake.Seat and handlebar can be folded.The maximum load capacity is 120KG.

    AI/ML Overview

    N/A

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