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

    HOME CARE VARIOUS MODELS OF SELF-ADHESIVE ELECTRODES

    K Number: K022917 · Decision Mar 4, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    243
    Registration Numbers
    243
    Same Product Code
    436
    Applicant Total
    4
    Review Days
    182

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    Basic Information

    Device Name
    HOME CARE VARIOUS MODELS OF SELF-ADHESIVE ELECTRODES
    K Number
    K022917
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1320
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Home Care Technology Co., Ltd.
    Date Received
    September 3, 2002
    Decision Date
    March 4, 2003
    Product Code
    GXY
    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
    GXY Electrode, Cutaneous

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    Other Clearances by Home Care Technology Co., Ltd.

    K Number Device Name
    K023000 HOME CARE VARIOUS MODELS OF POWERED MUSCLE STIMULATOR, HT-329M SERIES
    K022998 HOME CARE VAREIOUS MODELS OF POWERED MUSCLE STIMULATOR, HT-311, HT-311N, HT-312
    K023001 HOME CARE VARIOUS MODELS OF POWERED MUSCLE STIMULATOR, HT-326L