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

    Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA), Well-Life Incontinence Stimulation/EMG Electrode Probe, Well-Life Probe Electrode

    K Number: K222528 · Decision Dec 29, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    95
    Applicant Total
    22
    Review Days
    129

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    Basic Information

    Device Name
    Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA), Well-Life Incontinence Stimulation/EMG Electrode Probe, Well-Life Probe Electrode
    K Number
    K222528
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5320
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Well-Life Healthcare Limited
    Date Received
    August 22, 2022
    Decision Date
    December 29, 2022
    Product Code
    KPI
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KPI Stimulator, Electrical, Non-Implantable, For Incontinence

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    Other Clearances by Well-Life Healthcare Limited

    K Number Device Name
    K233054 Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator; TENS/EMS WITH Menstrual Relief Stimulator; Well-Life Pain Relief Stimulator; Menstrual Plus Stimulator
    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
    K123075 BUTTOCK MUSCLE STIMULATOR MODEL WL-2413B; BUTTOCK MUSCLE STIMULATOR MODE WL-2413E
    Search all 22 clearances from Well-Life Healthcare Limited →