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510(k) Data Aggregation

    K Number
    K100084
    Device Name
    MULTI FRAME WHEELCHAIR
    Manufacturer
    R82 A/S
    Date Cleared
    2010-04-12

    (90 days)

    Product Code
    IOR
    Regulation Number
    890.3850
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MULTI FRAME WHEELCHAIR

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

    The Multi Frame's intended function and use is provide mobility to children limited to a sitting position.

    Device Description

    The Wheelchair consists primarily of an aluminum frame, large rear wheels with hand rims for propelling the wheelchair or smaller rear wheels for attendant-only use, and smaller front privoting casters for steering and turning.

    AI/ML Overview

    I am sorry, but the provided document is a letter from the FDA regarding a 510(k) premarket notification for a Multi Frame Wheelchair. It does not contain information about acceptance criteria, device performance studies, or details relevant to artificial intelligence or machine learning model validation. Therefore, I cannot extract the requested information.

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