BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    LIMITED FUNCTION WL/OTC-TENS DEVICE, MODEL WL-2103A, WL-2203A, WL-2203B AND WL-2401

    K Number: K040512 · Decision May 27, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    184
    Registration Numbers
    184
    Same Product Code
    605
    Applicant Total
    6
    Review Days
    90

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    Basic Information

    Device Name
    LIMITED FUNCTION WL/OTC-TENS DEVICE, MODEL WL-2103A, WL-2203A, WL-2203B AND WL-2401
    K Number
    K040512
    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, Inc.
    Date Received
    February 27, 2004
    Decision Date
    May 27, 2004
    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

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    Other Clearances by Well-Life Healthcare, Inc.

    K Number Device Name
    K033857 T-TECH DIGITAL, MODEL WL-22XXA SERIES
    K030537 DIGI-PRO TENS/WL-2203B,2204B,2204B-P1,2204B-P2,2205B
    K020020 THE IZZZY-TENS (WL-2401), THE SLIM-TENS (WL-2402), THE MENS-TENS (WL2403), THE COMPACT TENS (WL-2302)
    K021359 DIGI-PRO TENS MODEL WL-2203 AND WL-2205
    K020314 DIGI-PRO TENS, MODEL WL-2204 AND WL-2205