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

    GEM-STONE ABDOMINAL TRAINING SYSTEM; MODEL GEM-TONE 310PE/320PE/330PE/340PE/350PE.

    K Number: K091833 · Decision Oct 16, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    191
    Registration Numbers
    191
    Same Product Code
    161
    Applicant Total
    14
    Review Days
    116

    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
    GEM-STONE ABDOMINAL TRAINING SYSTEM; MODEL GEM-TONE 310PE/320PE/330PE/340PE/350PE.
    K Number
    K091833
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5850
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Gemore Technology Co, Ltd.
    Date Received
    June 22, 2009
    Decision Date
    October 16, 2009
    Product Code
    NGX
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NGX Stimulator, Muscle, Powered, For Muscle Conditioning

    Similar 510(k) Clearances

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

    Diacore

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Zionic Pro Max (EMS)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    CoolTone

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Motive™ Muscle Stimulator for Lower Back (OT01-1003)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    truFlex

    FDA 510(k)
    FDA Class 2 ·Physical Medicine
    View all

    Other Clearances by Gemore Technology Co, Ltd.

    K Number Device Name
    K190988 GIM-STIM OTC TENS/EMS System
    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;
    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. →