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510(k) Data Aggregation

    K Number
    K222823
    Device Name
    AeroDVx Arm System
    Manufacturer
    Date Cleared
    2023-09-07

    (353 days)

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

    Sun Scientific Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The AeroDVx™ Arm System is comprised of a gradient compression sleeve, portable intermittent pneumatic pump and hand pump designed to provide static or intermittent pneumatic compression to the bicep and forearm, in both a clinical and outpatient setting. It is intended to provide treatment for: - . Enhancement of blood circulation - Reduction of post-operative pain and swelling . - Reduction of edema - Lymphedema . - Post immobilization edema . - Post mastectomy edema - Edema following trauma and sports injuries - Reducing wound healing time ● - . Lipedema
    Device Description
    The AeroDVx ™ Arm System is compression sleeve, electronic intermittent pneumatic pump for intermittent pneumatic compression therapy or DVT Prophylaxis. The AeroDVx™ Arm compression sleeves are composed of a family of non-sterile single patient use medical devices. The AeroDVx ™ Arm compression sleeves contain a single bladder with a built-in gradient profile and inelastic Velcro straps to affix it to the patient's arm. The AeroDVx ™ Compression Sleeve for the Arms are available in three sizes, small, medium and large. The sleeves are composed of two polyurethane laminates that are sealed together creating an internal bladder system. The Arm Sleeves were developed on a technology platform that allows the sleeves to be wearable, which is designed to provide mobility for patients during use. The bladder system contains circular and bar welds that were engineered with their spacing and location to provide a gradient compression profile when worn and inflated. An inflation source is attached to the inflation valve on the sleeve. The insertion of the inflation source into the check valve, opens the luer valve so that the bladder can be inflated or deflated based on the direction of airflow. There is an inflation source provided: a portable, battery-operated intermittent pneumatic pump, the AeroDVx™ Pump (cleared under k183349), to provide intermittent pneumatic compression and a hand pump for static inflation. The system is intended for clinical and outpatient use. The AeroDVx Arm system is developed on a wearable compression technology platform, which is designed to provide mobility for patients.
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    K Number
    K183349
    Device Name
    AeroDVx System
    Manufacturer
    Date Cleared
    2019-07-19

    (228 days)

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

    Sun Scientific Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The AeroDVx ™ System is comprised of a gradient compression sleeve, portable intermittent pneumatic pump, and hand pump designed to provide static or intermittent pneumatic compression to the calf and foot, in both the hospital and outpatient setting. It is intended to provide treatment for: 1. DVT Prophylaxis 2. Enhancement of blood circulation 3. Reduction of post-operative pain and swelling 4. Reduction of wound-healing time 5. Stasis dermatitis 6. Treatment and assistance of healing cutaneous ulceration 7. Venous stasis ulcers 8. Leg ulcers 9. Chronic venous insufficiency 10. Reduction of edema 11. Lymphedema
    Device Description
    The AeroDVx ™ System is comprised of a gradient compression sleeve, electronic intermittent pneumatic pump and hand pump to provide static and/or intermittent pneumatic compression for compression therapy or DVT Prophylaxis. The AeroDVx™ gradient compression sleeve is composed of a family of non-sterile single patient use medical devices. The AeroDVx ™ Gradient Compression Sleeve contains a single bladder with a built-in gradient profile and inelastic straps to affix it to the patient's leg. The AeroDVx TM Gradient Compression Sleeve is available in four sizes and two different lengths (standard and short). The wrap is composed of two polyurethane laminates that are sealed together creating an internal bladder system. The bladder system contains circular and bar welds that were engineered with their spacing and location to provide gradient compression profile when worn and inflated. An inflation source is attached to the inflation valve on the sleeve. The insertion of the inflation source onto the check valve of pressure opens the leur valve so that the bladder can be inflated or deflated based on the direction of airflow. There will be two inflation sources provided: a portable, battery-operated intermittent pneumatic pump, the AeroDVx™ Pump, to provide intermittent pneumatic compression and a hand pump to provide static compression. The system is intended for hospital and outpatient use.
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