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

    PRO TENS, MODEL WL-240 RX

    K Number: K080304 · Decision Jun 20, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    184
    Registration Numbers
    184
    Same Product Code
    605
    Applicant Total
    22
    Review Days
    136

    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
    PRO TENS, MODEL WL-240 RX
    K Number
    K080304
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Well-Life Healthcare Limited
    Date Received
    February 5, 2008
    Decision Date
    June 20, 2008
    Product Code
    GZJ
    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
    GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief

    Similar 510(k) Clearances

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

    STIMPOD NMS460 Nerve Stimulator

    FDA 510(k)
    FDA Class 2 ·Neurology

    actiTENS mini

    FDA 510(k)
    FDA Class 2 ·Neurology

    CP Relief Wand Rx - TENS/NMES

    FDA 510(k)
    FDA Class 2 ·Neurology

    Unipro (K-UNIPRO-US)

    FDA 510(k)
    FDA Class 2 ·Neurology

    TENSWave

    FDA 510(k)
    FDA Class 2 ·Neurology

    Electrical Neuromuscular Stimulator, Cure Trio

    FDA 510(k)
    FDA Class 2 ·Neurology
    View all

    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
    K222528 Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA), Well-Life Incontinence Stimulation/EMG Electrode Probe, Well-Life Probe Electrode
    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
    Search all 22 clearances from Well-Life Healthcare Limited →