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

    THERAPEUTIC ULTRASOUND AND STIMULATOR

    K Number: K935271 · Decision Feb 2, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    54
    Applicant Total
    70
    Review Days
    92

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    Basic Information

    Device Name
    THERAPEUTIC ULTRASOUND AND STIMULATOR
    K Number
    K935271
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5860
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Chattanooga Group, Inc.
    Date Received
    November 2, 1993
    Decision Date
    February 2, 1994
    Product Code
    IMG
    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
    IMG Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat

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    Other Clearances by Chattanooga Group, Inc.

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    K982321 VECTRA STIM MODELS 200 AND 400
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    K982828 FORTE, MODELS CPS 400 STIM, CPS 200 STIM
    K982830 FORTE, MODELS CPS 400 COMBO, CPS 200 COMBO
    K980718 PARA-CARE
    K974497 INTELECT
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