BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    GIM-STIM OTC TENS/EMS System

    K Number: K190988 · Decision Aug 16, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    160
    Registration Numbers
    160
    Same Product Code
    227
    Applicant Total
    14
    Review Days
    123

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    Basic Information

    Device Name
    GIM-STIM OTC TENS/EMS System
    K Number
    K190988
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Gemore Technology Co, Ltd.
    Date Received
    April 15, 2019
    Decision Date
    August 16, 2019
    Product Code
    NUH
    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
    NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter

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    Other Clearances by Gemore Technology Co, Ltd.

    K Number Device Name
    K150681 GEMORE OTC TENS
    K122944 GEMORE TRUE SINE INTERFERENTIAL STIMULATOR
    K122948 GEM-STIM COMBO STIMULATOR
    K120569 GEMORE TENS SYSTEM
    K102933 GEM-TONE BODY TRAINING SYSTEM
    K102926 GEMORE MUSCLE CONDITIONER;
    K091833 GEM-STONE ABDOMINAL TRAINING SYSTEM; MODEL GEM-TONE 310PE/320PE/330PE/340PE/350PE.
    K062675 GEMORE REUSEABLE SELF ADHESIVE ELECTRODE, MODELS WIRE SERIES, SNAP SERIES AND DOUBLE SIDE SERIES
    K060222 LOW BACK PAIN RELIEF SYSTEM /MODELS GM310PP,GM320PP,GM321PP, AND GM330PP
    K042559 GEM-TWIN TENS/ MODELS GM3XY/Z
    Search all 14 clearances from Gemore Technology Co, Ltd. →