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510(k) Data Aggregation

    K Number
    K243970
    Device Name
    Portable Wheelchair
    Manufacturer
    Intradin (Shanghai) Machinery Co., Ltd
    Date Cleared
    2025-03-07

    (74 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 :

    Portable Wheelchair

    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

    Portable Wheelchair

    AI/ML Overview

    The provided document is an FDA 510(k) clearance letter for a Portable Wheelchair (K243970). It confirms that the device is substantially equivalent to legally marketed predicate devices.

    However, this document does not contain any information regarding acceptance criteria, study details, performance metrics, sample sizes, ground truth establishment, or expert qualifications as typically associated with performance studies for AI/ML-driven medical devices or diagnostic tools.

    This letter is a regulatory approval notice, not a clinical or technical study report. Therefore, I cannot provide the requested information based on the input text.

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