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510(k) Data Aggregation

    K Number
    K192077
    Device Name
    Tua Face Fitness / Tua Trend Face
    Manufacturer
    Date Cleared
    2020-09-30

    (425 days)

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

    Vupiesse S.R.L

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Tua Face Fitness / Tua Trend Face is a device intended for facial stimulation and is indicated for Over-the-Counter cosmetic use.
    Device Description
    Tua Face Fitness /Tua Trend Face is a two-channel, battery-operated cosmetic device which is intended for use on the face. The device comprises a rechargeable electronic device which connects to an applicator wand that delivers electrical impulses to the face. The device operates by applying Transcutaneous Electrical Nerve Stimulation to the facial area. It means that the electrodes that are positioned on the skin must be wet with tap water to be conductive to generate of the electric pulses. The pads are made of pure cellulose backed by PVC. It is a surface device which comes in contact with skin. The duration of contact is less than or equal to 24 hours.
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