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

    PULSED AND CONTINUOUS SHORTWAVE APPAR.

    K Number: K781316 · Decision Sep 27, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    44
    Applicant Total
    7
    Review Days
    58

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    Basic Information

    Device Name
    PULSED AND CONTINUOUS SHORTWAVE APPAR.
    K Number
    K781316
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5290
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    General Theraphysical, Inc.
    Date Received
    July 31, 1978
    Decision Date
    September 27, 1978
    Product Code
    IMJ
    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
    IMJ Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat

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    Other Clearances by General Theraphysical, Inc.

    K Number Device Name
    K781319 THERAPY APPAR. 422 INTERFERENTIAL
    K781315 MUSCLE STIMULATION APPARATUS
    K781314 THERAPY UNIT & ELECTRODIAG.
    K781318 DYNATRON 406 ELECTROTHERAPY APPARATUS
    K781317 ULTRASONIC THERAPY APPARATUS, 407
    K781320 SHORTWAVE THERAPY APPAR. CURAMED 401