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510(k) Data Aggregation

    K Number
    K103247
    Device Name
    VASCUCOMP
    Manufacturer
    THERMOTEK, INC.
    Date Cleared
    2010-12-10

    (37 days)

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

    THERMOTEK, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    VascuComp™ AI Mode: The VascuComp™ compression system in AI Mode is used as an adjunct therapy for patients with ischemic disease of the lower extremities, due to one or more of the following causes: Minor Amputations, Angioplasty / Stent Failure, Arteriopathic Wounds, Graft Failure, Intermittent Claudication, Ischemia, Night Pain, Rest Pain, Small Vessel Discase, Ulcers. VascuComp™ DVT Mode: Decrease the risk of deep venous thrombosis (DVT). Aids the blood flow back to the heart. Treat and assist healing of cutaneous ulceration (wounds), reduce wound healing time, enhance arterial circulation (blood flow), reduce compartmental pressures, reduce edema (swelling), reduce the need for anticoagulant (blood thinning) medications. VascuComp™ L Mode: Treatment of Venous disorders and dysfunction of the "muscle pump".
    Device Description
    The VascuComp™ device is comprised of a reusable air-pump with user adjustable pressures, and various single-patient sleeves or garments containing discrete, segmental inflatable chambers to be externally applied over the affected extremity of the pationt. The Vascu Comp™ provides calibrated, intermittent, sequential compression.to the treatment site for optimum therapy for patients with ischemic disease of the lower extremities, by increasing arterial circulation, and to reduce the risk of the formation of DVT and to reduce or control peripheral edema. The Vascu Comp™ systems utilize microprocessor control with multiple sensors to ensure patient safety and system functionality, and to provide consistent and repeatable therapy modalities. Alarms are both visual on the unit display and audible. Alarms are in place to detect a potentially unsafe situation and to terminate therapy to protect the patient and the system.
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    K Number
    K061866
    Device Name
    NANOTHERM, VASCUTHERM AND PROTHERMO THERAPY WRAPS
    Manufacturer
    THERMOTEK, INC.
    Date Cleared
    2006-08-22

    (50 days)

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

    THERMOTEK, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    NanoTherm Indications: - Treatment of disorders associated with vascular or lymphatic insufficiency such as Chronic Venous Insufficiency (CVI), venous stasis ulcers, post-mastectomy edema and chronic lymphedema. - Reduction of edema associated with soft tissue injuries such as burns, postoperative edema, and ligament sprains. - Localized thermal therapy (hot or cold) for post traumatic and post surgical medical and/or surgical conditions. VascuTherm Indications: - Treatment of disorders associated with vascular or lymphatic insufficiency such as Chronic Venous Insufficiency (CVI), venous stasis ulcers, post-mastectomy edema and chronic lymphedema. - Reduction of edema associated with soft tissue injuries such as burns, postoperative edema, and ligament sprains. - 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. - Treat and assist 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.
    Device Description
    The NanoTherm device is comprised of a reusable pump (NanoTherm unit) and various single patient use inflatable wraps (NanoTherm Wraps). The VascuTherm device consists of a reusable pump (VascuTherm unit) and various single-patient use inflatable wraps (VascuTherm Wraps). The VascuTherm unit has additional equipment installed and specially designed wraps specifically for the preventive treatment of DVT. The NanoTherm unit thermal control therapy provides chilled fluid and heated fluid to the therapy site to reduce pain and swelling and compresses the extremity to enhance performance and fluid transfer and treatment of edema and lymphedema. The VascuTherm unit contains a DVT mode that is not present on the NanoTherm unit. This therapy mode is for air-only DVT compression therapy using air-only DVT wraps. The NanoTherm and VascuTherm systems utilize microprocessor control with multiple sensors to ensure safety and system functionality, and to provide consistent and repeatable therapy modalities. Alarms are both visual on the unit display and audible. Alarms are in place to detect a potentially unsafe situation and to terminate therapy to prevent patient injury. Possible unsafe situations are listed in the risk and hazard analysis covered in Appendices 16.3.A and 16.3.B.
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