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

    THERAPEUTIC STIMULATOR 2100 (TS-2100)

    K Number: K914904 · Decision Apr 28, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    170
    Registration Numbers
    170
    Same Product Code
    547
    Applicant Total
    8
    Review Days
    179

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    Basic Information

    Device Name
    THERAPEUTIC STIMULATOR 2100 (TS-2100)
    K Number
    K914904
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5850
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Myo/Kinetic Systems, Inc.
    Date Received
    November 1, 1991
    Decision Date
    April 28, 1992
    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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    K932399 THERAPEUTIC STIM 200 (TS-200)/200P (TS-200P)