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

    Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303)

    K Number: K182136 · Decision Oct 10, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    160
    Registration Numbers
    160
    Same Product Code
    227
    Applicant Total
    5
    Review Days
    430

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    Basic Information

    Device Name
    Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303)
    K Number
    K182136
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shenzhen Osto Technology Co., Ltd.
    Date Received
    August 6, 2018
    Decision Date
    October 10, 2019
    Product Code
    NUH
    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
    NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter

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