BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇦🇺 Australia

    ACUSTIM

    K Number: K014273 · Decision Jun 12, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    22
    Applicant Total
    2
    Review Days
    167

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    Basic Information

    Device Name
    ACUSTIM
    K Number
    K014273
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    S.H.P. Intl. Pty., Ltd.
    Date Received
    December 27, 2001
    Decision Date
    June 12, 2002
    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 S.H.P. Intl. Pty., Ltd.

    K Number Device Name
    K954334 ACUPLUS