BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    MEDX HOME

    K Number: K050022 · Decision May 5, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    423
    Registration Numbers
    423
    Same Product Code
    227
    Applicant Total
    6
    Review Days
    120

    Basic Information

    Device Name
    MEDX HOME
    K Number
    K050022
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5500
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    MEDX ELECTRONICS, INC.
    Date Received
    January 5, 2005
    Decision Date
    May 5, 2005
    Product Code
    ILY
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    ILY Lamp, Infrared, Therapeutic Heating

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