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

    Electrical Neuromuscular Stimulator (Cure Trio MC-310 iOS, Cure Trio MC-310 Android)

    K Number: K212285 · Decision Dec 22, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    160
    Registration Numbers
    160
    Same Product Code
    227
    Applicant Total
    5
    Review Days
    154

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    Basic Information

    Device Name
    Electrical Neuromuscular Stimulator (Cure Trio MC-310 iOS, Cure Trio MC-310 Android)
    K Number
    K212285
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Oriental Inspiration Limited
    Date Received
    July 21, 2021
    Decision Date
    December 22, 2021
    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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