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

    VERSA STIM 380, MUSCLE STIMULATOR

    K Number: K852077 · Decision Aug 21, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    170
    Registration Numbers
    170
    Same Product Code
    547
    Applicant Total
    6
    Review Days
    100

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    Basic Information

    Device Name
    VERSA STIM 380, MUSCLE STIMULATOR
    K Number
    K852077
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5850
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Electro-Med Health Industries, Inc.
    Date Received
    May 13, 1985
    Decision Date
    August 21, 1985
    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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