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

    TENS/FES/NMES ELECTRODES

    K Number: K983097 · Decision Sep 17, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    243
    Registration Numbers
    243
    Same Product Code
    436
    Applicant Total
    6
    Review Days
    389

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    TENS/FES/NMES ELECTRODES
    K Number
    K983097
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1320
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Uni-Patch, Inc.
    Date Received
    August 24, 1998
    Decision Date
    September 17, 1999
    Product Code
    GXY
    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
    GXY Electrode, Cutaneous

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (GXY), ordered by most recent decision date.

    BioWave BioWraps

    FDA 510(k)
    FDA Class 2 ·Neurology

    Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)

    FDA 510(k)
    FDA Class 2 ·Neurology

    MR Conditional Cup Electrodes

    FDA 510(k)
    FDA Class 2 ·Neurology

    Tutamen Self Adhesive Electrodes

    FDA 510(k)
    FDA Class 2 ·Neurology

    myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T)

    FDA 510(k)
    FDA Class 2 ·Neurology

    Ceribell Brain Monitor Headband

    FDA 510(k)
    FDA Class 2 ·Neurology
    View all

    Other Clearances by Uni-Patch, Inc.

    K Number Device Name
    K962910 SPEC T.E.N.S. PREWIRED REPOSITIONABLE TENS ELECTRODE - MODIFY
    K962332 TENS/FES/NMES ELECTRODES
    K961141 EASY FLEX TENS/FES/MNS ELECTRODES 2 ROUND MODEL 8200/2X2 MODEL 8220
    K925466 CONDUCT ALOE GEL, #UP239-8FL. OZ/#UP245 G-1 GALLON
    K871222 TANTONE MULTI-DAY #633 TENS ELECTRODE