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

    ELECTRONIC PULSE MASSAGER TENS ELECTRONIC PULSE MASSAGER

    K Number: K113544 · Decision Jul 27, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    179
    Registration Numbers
    179
    Same Product Code
    601
    Applicant Total
    2
    Review Days
    239

    Basic Information

    Device Name
    ELECTRONIC PULSE MASSAGER TENS ELECTRONIC PULSE MASSAGER
    K Number
    K113544
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    PROSPERA CORPORATION
    Date Received
    December 1, 2011
    Decision Date
    July 27, 2012
    Product Code
    GZJ
    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
    GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief

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    Other Clearances by PROSPERA CORPORATION

    K Number Device Name
    K122744 PROSPERA OTC TENS ELECTRONIC PULSE MASSAGER