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510(k) Data Aggregation

    K Number
    K182400
    Device Name
    Solax Powered Wheelchair (Models: S7101, S7103)
    Manufacturer
    Dongguan Prestige Sporting Goods Co., Ltd
    Date Cleared
    2020-04-14

    (588 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 :

    Solax Powered Wheelchair (Models: S7101, S7103)

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

    The Solax Powered Wheelchair 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

    This document is a 510(k) clearance letter from the FDA for a powered wheelchair, specifically the Solax Powered Wheelchair (Models: S7101, S7103). It confirms that the device is substantially equivalent to legally marketed predicate devices.

    However, the provided text does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies (MRMC or standalone) for an AI/CAD product.

    This document is purely an administrative FDA clearance for a physical medical device (a powered wheelchair), and therefore none of the requested information about AI/CAD validation studies is present.

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