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510(k) Data Aggregation

    K Number
    K232001
    Device Name
    Nu Skin RenuSpa iO
    Manufacturer
    NSE Products, Inc
    Date Cleared
    2023-11-21

    (139 days)

    Product Code
    NFO
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    NSE Products, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Nu Skin RenuSpa iO is intended for body skin stimulation and is indicated for over-the-counter cosmetic use.
    Device Description
    Nu Skin RenuSpa iO is a hand-held, portable, rechargeable microcurrent device used to stimulate certain parts of the body for aesthetic purposes. It is used with a conductive medium. It contains a rechargeable Lithium-ion battery that is recharged with a USB-enabled inductive charger. Nu Skin RenuSpa iO is inductively charged by the supplied Nu Skin RenuSpa iO charging stand. Nu Skin RenuSpa iO is designed to mechanically rest on the charging stand in a manner that ensures proper alignment for charging. The charging stand connects to an external AC/DC USB Power supply adapter via a short length of cable terminated with USB-A Male connection. Nu Skin RenuSpa iO is indicated for use only on healthy, unbroken skin. Nu Skin RenuSpa iQ uses a combination of LED lights and audio feedback. Nu Skin RenuSpa iO is sold in the United States in a kit with the conductive medium (510k cleared conductive GEL K022006). In all cases the Nu Skin RenuSpa iO and Charger user manual are provided to the user.
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