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

    UNI-TENS XL TENS

    K Number: K861896 · Decision Sep 9, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    184
    Registration Numbers
    184
    Same Product Code
    605
    Applicant Total
    7
    Review Days
    116

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    Basic Information

    Device Name
    UNI-TENS XL TENS
    K Number
    K861896
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Solcoor, Inc.
    Date Received
    May 16, 1986
    Decision Date
    September 9, 1986
    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 Solcoor, Inc.

    K Number Device Name
    K882386 AGAR 3K NEUROMUSCULAR STIMULATOR
    K882387 AGAR 4000 NEUROMUSCULAR STIMULATOR
    K862454 AGAR 7K TENS INSTRUMENT
    K861895 UNI-TENS
    K861894 AGAR 9K TENS
    K851265 PEAK FLOWMETERS FOR SPIROMETRY