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510(k) Data Aggregation

    K Number
    K191951
    Device Name
    Avazzia OTC TENS for aesthetics, model BEST-AV1™: EZZI-LIFT™ Device
    Manufacturer
    Avazzia, Inc
    Date Cleared
    2021-04-27

    (645 days)

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

    Avazzia, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Avazzia OTC TENS for aesthetics, model BEST-AV1™: EZZI-LIFT™ Device is indicated for over-the-counter aesthetic use including facial and neck stimulation or body skin stimulation.
    Device Description
    Candidate device is a handheld, AA battery-operated portable device for use in the home or clinic. It has pre-set modes and is for over-the-counter use in the home or a clinical setting. The candidate device uses transcutaneous electrical stimulation (TENS) for aesthetic use for facial, neck, and body stimulation. The EZZI-LIFT device has built-in electrodes. Accessories, listed below, are also available to be used with the device.
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    K Number
    K162392
    Device Name
    Avazzia
    Manufacturer
    AVAZZIA, INC.
    Date Cleared
    2017-05-12

    (259 days)

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

    AVAZZIA, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Transcutaneous Electrical Nerve Stimulation (TENS) for the temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back of the neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
    Device Description
    Avazzia OTC TENS electronic pulse massage devices are electrically powered device intended for overthe-counter use and used to apply a microcurrent electrical pulses to electrodes on a user's skin to relieve pain. They are easy-to-use, handheld, AA battery-operated portable devices for use in the home or clinic. The candidate devices have pre-set modes. The devices are portable, battery operated microcurrent electrical stimulation device that applies charge and power to the tissue through electrodes where maximum power delivered to the load is controlled and limited, and an automatic shut off is implemented. The user can apply the built-in onboard electrodes or place self-adhesive conductive electrodes where indicated and apply stimulation for a period of time. The user controls the output by selecting the mode and power setting.
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    K Number
    K123099
    Device Name
    Best-AV2 Pro-Sport(tm)
    Manufacturer
    AVAZZIA, INC.
    Date Cleared
    2014-05-23

    (598 days)

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

    AVAZZIA, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Pro-Sport™ is indicated for: - . symptomatic relief and management of chronic, intractable pain - adjunctive treatment in the management of post-surgical and post-traumatic pain .
    Device Description
    The candidate Pro-Sport Avazzia device is a micro-current transcutaneous electro-stimulation device. It is an easy-to-use, handheld, AA battery-operated portable device for use in the home or clinic. The device is a portable, battery operated microcurrent electrical stimulation device that applies charge and power to the tissue through electrodes where maximum power delivered to the load is controlled and limited, and an automatic shut off is implemented. The user can passively place the electrodes where indicated and apply stimulation for a period of time. The user controls the output by selecting the preset mode and power setting. The device's controls and visual indicators are located on the upper side of the case and on the upper cover. The Pro-Sport™ device incorporates a more sophisticated digital liquid crystal display user interface to help the user select the mode and see parameters like the power level, time, and other information and has one mode that allows practitioners to set up their own therapy signals.
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    K Number
    K062641
    Device Name
    BODY-STIM, BIOMODULATOR, BEST-RSI, BEST PRO, MODEL BEST-AV1
    Manufacturer
    AVAZZIA, INC.
    Date Cleared
    2007-04-30

    (236 days)

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

    AVAZZIA, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For symptomatic relief and management of chronic, intractable pain, and adjunctive treatment in the management of post-surgical and posttraumatic pain.
    Device Description
    The four Avazzia Biofeedback Electro-Stimulation Technology (BEST) devices are biofeedback, micro-current transcutaneous electro-stimulation devices for symptomatic relief and management of chronic, intractable pain, and adjunctive treatment in the management of post-surgical and post-traumatic pain. They are easy-to-use, handheld, AA battery-operated portable devices for use in the home or clinic.
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