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

    TRU-SOUND ULTRASOUND THERAPY UNIT

    K Number: K871633 · Decision May 28, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    44
    Applicant Total
    2
    Review Days
    31

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    Basic Information

    Device Name
    TRU-SOUND ULTRASOUND THERAPY UNIT
    K Number
    K871633
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5290
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Tru-Trac Therapy Products, Inc.
    Date Received
    April 27, 1987
    Decision Date
    May 28, 1987
    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 Tru-Trac Therapy Products, Inc.

    K Number Device Name
    K881211 TRU-TECH 310 ULTRASOUND THERAPY UNIT #310