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

    ULTRASONIC THERAPY APPARATUS, 407

    K Number: K781317 · Decision Oct 3, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    88
    Applicant Total
    7
    Review Days
    64

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    Basic Information

    Device Name
    ULTRASONIC THERAPY APPARATUS, 407
    K Number
    K781317
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5300
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    General Theraphysical, Inc.
    Date Received
    July 31, 1978
    Decision Date
    October 3, 1978
    Product Code
    IMI
    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
    IMI Ultrasonic Diathermy 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
    K781320 SHORTWAVE THERAPY APPAR. CURAMED 401
    K781316 PULSED AND CONTINUOUS SHORTWAVE APPAR.