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510(k) Data Aggregation

    K Number
    K200978
    Device Name
    Electric Wheelchair (Model: S7110)
    Manufacturer
    Dongguan Prestige Sporting Goods Co., Ltd.
    Date Cleared
    2021-04-16

    (368 days)

    Product Code
    ITI
    Regulation Number
    890.3860
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Electric Wheelchair (Model: S7110)

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

    The Electric wheelchair (Model: S7110) is a motor driven, indoor transportation vehicle with the intended use to provide mobility to a disabled or elderly limited to a seated position.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for an "Electric Wheelchair (Model: S7110)". It confirms that the device is substantially equivalent to legally marketed predicate devices.

    The letter does not contain information about acceptance criteria, a specific study proving device performance against acceptance criteria, sample sizes, data provenance, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or ground truth details.

    The document primarily addresses the regulatory approval process and includes the Indications for Use statement for the electric wheelchair.

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