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

    OTC COMBO TENS/EMS SYSTEM

    K Number: K141299 · Decision Nov 14, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    158
    Registration Numbers
    158
    Same Product Code
    216
    Applicant Total
    16
    Review Days
    179

    Basic Information

    Device Name
    OTC COMBO TENS/EMS SYSTEM
    K Number
    K141299
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    WELL-LIFE HEALTHCARE LIMITED
    Date Received
    May 19, 2014
    Decision Date
    November 14, 2014
    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 WELL-LIFE HEALTHCARE LIMITED

    K Number Device Name
    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
    K133723 OTC PATCH
    K123075 BUTTOCK MUSCLE STIMULATOR MODEL WL-2413B; BUTTOCK MUSCLE STIMULATOR MODE WL-2413E
    K121353 MINI PATCH
    K102786 WELL-LIFE OTC EMS SYSTEM
    K100399 4 CHANNELS MULTIPLE MODEL DIGITAL ELECTRICAL STIMULATOR, MODEL NUVOSTIM IV, WL-2504A
    K091757 OTC TENS FOR ARM AND LEG PAIN RELIEF, MODEL WL-2407
    K092763 IF TRUE SINE INTERFERENTIAL STIMULATOR, WL-2206D
    K082065 WELL LIFE SELF ADHESIVE ELECTRODE / MODELS: CM, FA, PU AND SP
    Search all 16 clearances from WELL-LIFE HEALTHCARE LIMITED →