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510(k) Data Aggregation

    K Number
    K240272
    Device Name
    Electric Scooter (M2085, S2091)
    Manufacturer
    Guangdong Prestige Technology Co., Ltd.
    Date Cleared
    2024-07-16

    (167 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 :

    Electric Scooter (M2085, S2091)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    It 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.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for an "Electric Scooter (M2085, S2091)". This document does not contain information about acceptance criteria or a study proving that a device (specifically an AI/ML medical device, which is what your query implies) meets those criteria.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study based on the provided text. The document discusses regulatory approval for an electric scooter, not an AI software or a clinical study's findings.

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