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

    MINI-1 TRANSCUTANEOUS ELEC-NERVE STIM

    K Number: K834215 · Decision Jan 3, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    184
    Registration Numbers
    184
    Same Product Code
    605
    Applicant Total
    8
    Review Days
    29

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    Basic Information

    Device Name
    MINI-1 TRANSCUTANEOUS ELEC-NERVE STIM
    K Number
    K834215
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Th Charters, Inc.
    Date Received
    December 5, 1983
    Decision Date
    January 3, 1984
    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 Th Charters, Inc.

    K Number Device Name
    K873357 ELECTROBLOC TRANS. ELECTRICAL NERVE BLOCK GENERA.
    K861501 EXER-STIM 2
    K851967 TORQUE FEEDBACK METER
    K851946 REMOTE SPEED CONTROL
    K831850 NEURO-PULSER 2 TRANSCUTAN. ELEC. NERVE
    K822056 EXER-STIM CONTROLLER
    K800486 STIM-EX 201