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510(k) Data Aggregation

    K Number
    K143197
    Device Name
    Nice1
    Date Cleared
    2014-12-23

    (47 days)

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

    NICE RECOVERY SYSTEMS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Nicel combines cold and compression therapies. It is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain where cold and compression are indicated. It is intended to be used by or on the order of a healthcare professional in hospital, outpatient clinics, athletic training settings, or home settings.
    Device Description
    Nice1 is a cold and compression therapy device used to aid recovery and reduce pain associated with soft tissue injuries. The device works by circulating cooled water and air through a therapy wrap that is placed on the injured body part. The cooled water circulates through the therapy wrap and provides cold therapy; the air inflates the therapy wrap causing it to compress around the injured body part. The Nice1 uses thermoelectric technology to chill the water. The Nice1 consists of 3 key components: 1. The control unit which chills the water and contains the pneumatic system for inflating and deflating the therapy wraps. 2. The hose assembly which connects to the control unit to the therapy wrap and provides conduits for the flow of water and air to and from the therapy wrap. 3. The therapy wrap which is placed on the patient and wraps around the injured body part to deliver cold and compression therapy. The control unit is an electromechanical, software-controlled device housed in a plastic enclosure. The device is approximately 8 x 7.64 x 8" and weighs 10 lbs. Inside the control unit are a thermoelectric heat exchange for cooling the water, a pneumatic system to control the flow of air to/from the therapy wrap to regulate compression, and electronics to control the therapy. Integrated into the plastic enclosure is graphical touch screen that displays outputs and receives inputs from the user. Temperature, compression levels and therapy duration are selected by the user via the graphical touch screen interface and controlled by a microprocessor. The control unit contains a 300ml reservoir that is filled with water by the user. Water from the reservoir is cooled by passing through the thermoelectric heat exchange; it is then pumped from the control unit through the hose assembly, through the therapy wrap and then returns to the control unit to be re-chilled. Temperature is controlled in five (5) levels ranging in temperature from 59°F to 43°F. Compression can be set at low, medium and high settings ranging from 0 mmHg to 75 mmHg. The compression cycles from high to low on 2 – 5 minute intervals to achieve Intermittent Pneumatic Compression. The hose assembly is 6 feet long and consists of a foam rubber outer sheath to provide insulation and 3 urethane tubes that carry water and air to/from the control unit and therapy wrap. The therapy wraps are comprised of 3 layers of urethane coated nylon that are welded together to make 2 separate air and liquid tight layers for the air and water. The therapy wraps are tailored to fit specific body parts. At the current time the company is only marketing a knee wrap. Therapy wraps use a Velcro closure to allow for customized fitting for different patients.
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