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

    THERAPY UNIT & ELECTRODIAG.

    K Number: K781314 · Decision Oct 3, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    243
    Registration Numbers
    243
    Same Product Code
    436
    Applicant Total
    7
    Review Days
    64

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    Basic Information

    Device Name
    THERAPY UNIT & ELECTRODIAG.
    K Number
    K781314
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1320
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    General Theraphysical, Inc.
    Date Received
    July 31, 1978
    Decision Date
    October 3, 1978
    Product Code
    GXY
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GXY Electrode, Cutaneous

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    Other Clearances by General Theraphysical, Inc.

    K Number Device Name
    K781319 THERAPY APPAR. 422 INTERFERENTIAL
    K781315 MUSCLE STIMULATION APPARATUS
    K781318 DYNATRON 406 ELECTROTHERAPY APPARATUS
    K781317 ULTRASONIC THERAPY APPARATUS, 407
    K781320 SHORTWAVE THERAPY APPAR. CURAMED 401
    K781316 PULSED AND CONTINUOUS SHORTWAVE APPAR.