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    FDA 510(k) FDA unclassified Substantially Equivalent 🇹🇼 Taiwan

    ACULIFE, MODEL SMW-01

    K Number: K051197 · Decision Mar 28, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    22
    Applicant Total
    2
    Review Days
    322

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    Basic Information

    Device Name
    ACULIFE, MODEL SMW-01
    K Number
    K051197
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Inno-Health Technology, Inc.
    Date Received
    May 10, 2005
    Decision Date
    March 28, 2006
    Product Code
    BWK
    Advisory Committee
    Unknown
    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
    BWK Stimulator, Electro-Acupuncture

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    Other Clearances by Inno-Health Technology, Inc.

    K Number Device Name
    K091933 ELECTRO-ACUPUNCTURE: ACULIFE/MODEL IDOC-01