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510(k) Data Aggregation

    K Number
    K151158
    Device Name
    ALP VasQcare Take Home System
    Date Cleared
    2015-12-10

    (223 days)

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

    Currie Medical Specialties, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Alternating Leg Pressure® (ALP®) VasQcare™ System is a non-invasive system for reducing the incidence of deep vein thrombosis. The application of external intermittent pneumatic compression has six effects: 1. Increases blood flow velocity 2. Reduces the risk of deep vein thrombosis 3. Enhances blood circulation 4. Reduces pain and swelling 5. Reduces wound healing time 6. Aids in the treatment and healing of stasis dermatitis, venous stasis, arterial and diabetic leg ulcers, chronic vein insufficiency and reduction of edema in the lower limbs The ALP® VasQcare™ System consists of a pump and a pair of single use calf sleeves. The pump provides intermittent cycles of compressed air, which alternately inflate the calf sleeves. The compression, when applied properly to the patient, increases blood velocity back to the heart and helps to prevent deep vein thrombosis. The pump operates on timed cycles consisting of approximately 12 seconds of inflation where the calf sleeve compresses the limb followed by approximately 48 seconds of deflation where there is no pressure applied to the limb. Each limb compresses once per minute. The ALP® VasQcare™ System may be used on patients at risk for developing deep vein thrombosis and in conjunction with medical therapy for high-risk patients.
    Device Description
    Currie Medical Specialties (CMS) ALP® VasQcare™ System provides intermittent pneumatic pressure to a patient's leg for the prevention of deep vein thrombosis (DVT). When the compression sleeve is inflated, the veins collapse, which forces blood to move upward toward the heart. After compression is complete, the sleeves deflate which allows the veins to reopen and bring oxygenated blood to the calf. The VasQcare™ pump controller predicates the inflation and deflation sequence.
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    K Number
    K143317
    Device Name
    Currie Medical ALP Pediatric Calf Compression Sleeves (all sizes)
    Date Cleared
    2015-01-20

    (62 days)

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

    Currie Medical Specialties, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Currie Medical ALP Pediatric Calf Compression Sleeves (all sizes) are recommended for the use in pediatric patients for whom external compression the ALTERNATING LEG PRESSURE® (ALP®) SYSTEM is indicated to reduce the incidence of deep vein thrombosis and resulting pulmonary embolism due to the presence of risk factors for thrombosis formation.
    Device Description
    Currie Medical Specialties (CMS) ALP® pediatric compression sleeves are compression devices, which when attached to the ALP® 501 Pump System, provide intermittent pneumatic pressure to a patient's leg for the prevention of deep vein thrombosis (DVT). When the compression sleeve is inflated, the veins collapse, which forces blood to move upward the heart. After compression is complete, the sleeves deflate which allows the veins to reopen and bring oxygenated blood to the calf. The inflation and deflation sequence is predicated by the ALP® 501 Pump System controller.
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    K Number
    K140092
    Device Name
    CURRIE MEDICAL REPROCESSED ALP CALF/THIGH/FOOT COMPRESSION SLEEVE (ALL SIZES)
    Date Cleared
    2014-04-16

    (92 days)

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

    CURRIE MEDICAL SPECIALTIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The intended use of this device, as well as the predicate device, is to provide external limb compression in order to artificially imitate the pumping action of the leg muscles. This provides muscle contraction required by the venous return system, thereby helping to prevent venous stasis and subsequent thrombosis and embolism. The cyclic and alternating inflation of the garments closely simulates the normal healthy pumping action of the limb muscles to stimulate deep venous blood flow and the reactivation or increase in the body's fibrinolytic system. The Currie Medical Reprocessed ALP Calf, Thigh and Foot Compression Sleeves (all sizes) are recommended for the use in patients for whom external compression therapy using the ALTERNATING LEG PRESSURE® (ALP®) SYSTEM is indicated to reduce the incidence of deep vein thrombosis and resulting pulmonary embolism due to the presence of risk factors for thrombosis formation.
    Device Description
    Currie Medical Specialties (CMS) ALP reprocessed compression sleeves are compression devices, which when attached to the ALP 501 Pump System, provide intermittent, sequentially gradient pressure to a patients leg/foot for the prevention of deep vein thrombosis (DVT). When the compression sleeve is inflated, the veins collapse which forces blood to move upward the heart. After compression is complete, the sleeves deflate which allows the veins to reopen and bring oxygenated blood to the calf, thigh or foot. The inflation and deflation sequence is predicated by the ALP 501 Pump System controller.
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    K Number
    K112311
    Device Name
    ALP 501 RB PUMP SYSTEM
    Date Cleared
    2011-09-01

    (21 days)

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

    CURRIE MEDICAL SPECIALTIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ALP® 501 RB Pump system is a prescriptive device that induces controlled compression of the calf, the foot or combined compression of both. The ALP® 501 RB Pump System is intended for use by patients and medical professionals in treating many conditions, such as: - Reduce the incidence of deep vein thrombosis (DVT) and pulmonary embolism due to the presence of risk factors for thrombosis formation - Enhancement of arterial blood flow - Reduction of post-operative pain and swelling - Reduction of compartmental pressure after tissue trauma
    Device Description
    The ALP® 501 RB Pump is a prescriptive, pneumatic compression device designed to apply compression to the lower limb. The ALP® 501 RB pump is compact this making it a portable ambulant system. The ALP® 501 RB pump provides the user with an option of battery operation in addition to the operation from the mains option. The ALP® 501 RB pump is easy to use and provides the user with three treatment options: compression of the foot, compression of the calf, or combined compression of both (one foot and one calf). The foot and calf compression program fills a garment bladder and decompresses. The device is composed of three main sub-systems: - 1) A portable pneumatic pump unit, - 2) A pair of garments (calf and/or foot) and - 3) Pneumatic connecting tubes. Inflation and deflation of the garments are controlled by the pump system. The inflation and deflation produces a massage on the patient limb in order to stimulate the natural flow of the body fluids.
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