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510(k) Data Aggregation

    K Number
    K020100
    Device Name
    SL 803, SL 804, SL 807, SL 809, SL 506, SL 501, SL 805 AND SL 801 MECHANICAL WHEELCHAIRS
    Manufacturer
    REGULATORY INSIGHT, INC.
    Date Cleared
    2002-03-08

    (56 days)

    Product Code
    IOR
    Regulation Number
    890.3850
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The SL 803, SL 804, SL 807, SL 809, SL 506, SL 501, SL 805 and SL 801 Mechanical Wheelchairs are manually operated devices with wheels that are intended for medical purposes to provide mobility to persons restricted to a sitting position.

    Device Description

    Not Found

    AI/ML Overview

    This is a 510(k) clearance letter for a series of wheelchairs, not a study report for an AI/ML powered device. The document does not contain information about acceptance criteria or a study proving that a device meets such criteria because it pertains to a different type of medical device and regulatory process.

    Therefore, I cannot provide the requested information based on the given input.

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