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

    AGAR 7K TENS INSTRUMENT

    K Number: K862454 · Decision Mar 25, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    179
    Registration Numbers
    179
    Same Product Code
    601
    Applicant Total
    7
    Review Days
    271

    Basic Information

    Device Name
    AGAR 7K TENS INSTRUMENT
    K Number
    K862454
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    SOLCOOR, INC.
    Date Received
    June 27, 1986
    Decision Date
    March 25, 1987
    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
    K861896 UNI-TENS XL TENS
    K861894 AGAR 9K TENS
    K861895 UNI-TENS
    K851265 PEAK FLOWMETERS FOR SPIROMETRY