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510(k) Data Aggregation

    K Number
    K191897
    Device Name
    Solax Electric Scooter (Models: S3023, S3024, S3025, S3026)
    Manufacturer
    Dongguan Prestige Sporting Goods Co., Ltd.
    Date Cleared
    2021-02-10

    (575 days)

    Product Code
    INI
    Regulation Number
    890.3800
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Solax Electric Scooter (Models: S3023, S3024, S3025, S3026)

    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

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a Solax Electric Scooter, a motorized three-wheeled vehicle. It does not contain any information about an AI/ML-based medical device, its acceptance criteria, or performance study details.

    Therefore, I cannot provide the requested information regarding acceptance criteria and performance study for an AI/ML device based on the provided text. The document is strictly about a physical mobility device.

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