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

    BUTTOCK MUSCLE STIMULATOR MODEL WL-2413B; BUTTOCK MUSCLE STIMULATOR MODE WL-2413E

    K Number: K123075 · Decision Jul 11, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    191
    Registration Numbers
    191
    Same Product Code
    161
    Applicant Total
    22
    Review Days
    283

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    Basic Information

    Device Name
    BUTTOCK MUSCLE STIMULATOR MODEL WL-2413B; BUTTOCK MUSCLE STIMULATOR MODE WL-2413E
    K Number
    K123075
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    890.5850
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Well-Life Healthcare Limited
    Date Received
    October 1, 2012
    Decision Date
    July 11, 2013
    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

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    Other Clearances by Well-Life Healthcare Limited

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    K220524 Well-Life Mini TENS Stimulator(WL-23XXC/WL-23XXE Series)
    K213091 Well-Life TENS/EMS/Heating Stimulator
    K200942 Well-Life Garment Electrodes (GM Series)
    K172809 OTC Combo TENS/EMS System
    K162663 WELL LIFE Rx Wireless TENS/EMS Stimulator, model WR-2603/2603A, WR-2604/2604A and WR-2605/2605A
    K161453 WELL LIFE Wireless TENS/EMS Stimulator, Models WR-2605/2605A
    K141299 OTC COMBO TENS/EMS SYSTEM
    K133723 OTC PATCH
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