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    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    UltraTENS

    K Number: K142976 · Decision Aug 26, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    88
    Applicant Total
    25
    Review Days
    316

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    Basic Information

    Device Name
    UltraTENS
    K Number
    K142976
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5300
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Shenzhen Dongdixin Technology Co., Ltd.
    Date Received
    October 14, 2014
    Decision Date
    August 26, 2015
    Product Code
    IMI
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    IMI Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat

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