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510(k) Data Aggregation

    K Number
    K022696
    Device Name
    TEH LIN POWERED WHEELCHAIR, MODEL MDG-201
    Manufacturer
    TEH LIN PROSTHETIC & ORTHOPAEDIC, INC.
    Date Cleared
    2003-02-07

    (178 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 :

    TEH LIN POWERED WHEELCHAIR, MODEL MDG-201

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

    The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a powered wheelchair. It does not contain information about acceptance criteria or a study that proves the device meets acceptance criteria. The letter confirms that the device, "The Lin Powered Wheelchair, Model MDG-201," is substantially equivalent to legally marketed predicate devices. This means that its safety and effectiveness are considered to be similar to other devices already on the market, but it does not detail specific performance studies or acceptance criteria beyond regulatory compliance.

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