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510(k) Data Aggregation

    K Number
    K121001
    Device Name
    COPRESSION SYSTEMS (MODELS CMP-001 AND CMP-002)
    Date Cleared
    2012-04-17

    (15 days)

    Product Code
    Regulation Number
    870.5800
    Why did this record match?
    Applicant Name (Manufacturer) :

    NOVITAS MEDICAL, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Compression System is intended to function as an intermittent, sequential pneumatic compression device and each model provides the following specific therapeutic functions: The CMP-001 (Compression Plus) is intended for: - Treatment of disorders associated with vascular or lymphatic insufficiency such as . Chronic Venous Insufficiency (CVI), venous stasis ulcers, post-mastectomy edema, chronic lymphedema. - Reduction of edema associated with soft tissue injuries such as burns, postoperative . edema, and ligament sprains. - Optional localized thermal therapy (hot or cold) for post traumatic and post surgical . medical and/or surgical conditions - Aids the blood flow back to the heart . - Treats and assists healing of cutaneous ulceration (wounds), reduce would healing ● time enhance arterial circulation (blood flow), reduce compartmental pressures, reduce edema (swelling), reduce the need for anticoagulant (blood thinning) medications The CMP-002 (DVTmax) is intended for: - Treatment of disorders associated with vascular or lymphatic insufficiency such as ● Chronic Venous Insufficiency (CVI), venous stasis ulcers, post-mastectomy edema chronic lymphedema - Reduction of edema associated with soft tissue injuries such as burns, postoperative . edema, and ligament sprains - Optional localized thermal therapy (hot or cold) for post traumatic and post surgical ● medical and/or surgical conditions - Decrease the risk of deep venous thrombosis (DVT) . - Aids the blood flow back to the heart, . - Treats and assists healing of cutaneous ulceration (wounds), reduce would healing ● time, enhance arterial circulation (blood flow), reduce compartmental pressures, reduce edema (swelling), reduce the need for anticoagulant (blood thinning) medications
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