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

    RELIEFBAND TENS UNIT (MODIFICATION)

    K Number: K961050 · Decision Aug 1, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    184
    Registration Numbers
    184
    Same Product Code
    605
    Applicant Total
    2
    Review Days
    540

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    Basic Information

    Device Name
    RELIEFBAND TENS UNIT (MODIFICATION)
    K Number
    K961050
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Maven Labs, Inc.
    Date Received
    February 8, 1996
    Decision Date
    August 1, 1997
    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 Maven Labs, Inc.

    K Number Device Name
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