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510(k) Data Aggregation

    K Number
    K202693
    Device Name
    NeoWave Pain Relief and Recovery System, Model# T16-2020
    Manufacturer
    Date Cleared
    2021-03-05

    (171 days)

    Product Code
    Regulation Number
    890.5650
    Why did this record match?
    Applicant Name (Manufacturer) :

    Eva Medtec, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The NeoWave Pain Relief and Recovery System is indicated for the temporary relief of minor muscle aches and pains and for the temporary increase in circulation to the treated areas in good health. The NeoWave Pain Relief and Recovery System simulates the kneading and stroking of tissues by using inflatable air channels.
    Device Description
    The NeoWave Pain Relief and Recovery System Model # T16-2020 is a reusable, nonsterile therapy device intended to provide a gentle, rhythmic, soothing sensation using timed, pre-programed air pressure to inflate and deflate air channels within the therapy attachments. Each air channel inflates then deflates one at a time, to simulate the press and release action of the human hand by manipulating the soft tissues of the body relieving pain and increasing circulation. This device is a gradient, sequential, pneumatic compression device intended for the temporary relief of minor muscle aches and pains and for the temporary increase in circulation to the treated areas in people who are in good health. The NeoWave Pain Relief and Recovery System simulates the kneading and stroking of tissues by using inflatable air channels. The NeoWave Pain Relief and Recovery System consists of an air compressor, valve module(s) and a therapy attachment working together as one unit. The therapy attachments contain one or two valve modules that connect to the Controller Unit via a series of receptacles, tubing, and cabling. The system uses an external power supply of 12V DC. The Therapy Attachments/Cushions consist of inflatable welded pads with 8 or 16 air channels. The massage direction is distal to proximal (toward the heart). The sequential inflation cycle inflates then deflates one air channel at a time, for 3, 4 or 5 seconds allowing the user/patient to adjust the pressure. The therapy attachment/cushion works under the action of the valve module sensor and microprocessor.
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