BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    T.E.A.R. TECH3 MODEL #44TT03

    K Number: K030507 · Decision May 20, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    166
    Registration Numbers
    166
    Same Product Code
    543
    Applicant Total
    6
    Review Days
    90

    Basic Information

    Device Name
    T.E.A.R. TECH3 MODEL #44TT03
    K Number
    K030507
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5850
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    VISION QUEST INDUSTRIES, INC.
    Date Received
    February 19, 2003
    Decision Date
    May 20, 2003
    Product Code
    IPF
    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
    IPF Stimulator, Muscle, Powered

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