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

    MEGA PULSE THERAPY UNIT

    K Number: K841874 · Decision May 31, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    44
    Applicant Total
    10
    Review Days
    24

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    Basic Information

    Device Name
    MEGA PULSE THERAPY UNIT
    K Number
    K841874
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5290
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Physio Technology, Inc.
    Date Received
    May 7, 1984
    Decision Date
    May 31, 1984
    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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    K843351 OMNISTIM II COMBIN. THERAPY SYS
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    K841278 OMNISTIM III INTERFERENTIAL THERAPY