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510(k) Data Aggregation

    K Number
    K181217
    Device Name
    VesoFlow Lite DVT Compression Device
    Manufacturer
    Caremed Supply, Inc.
    Date Cleared
    2018-08-05

    (90 days)

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

    Caremed Supply, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Caremed Supply Inc. VesoFlow Lite Deep Vein Thrombosis (DVT) Compression Device is intended to increase venous blood flow in at risk patients in order to help prevent deep vein thrombosis.
    Device Description
    The VesoFlow Lite DVT Compression Device is an Intermittent Pneumatic Compression System that counteracts blood stasis and coagulation changes; two of the three major factors that promote deep vein thrombosis (DVT) a potentially life threatening condition which can lead to pulmonary embolism. The VesoFlow Lite is a non-invasive mechanical prophylactic system that massages the feet or legs in a wavelike, milking motion that promotes blood flow and deters thrombosis, helping to empty pooled or static blood from the valve cusps of the femoral vein. Fibrinolytic activity is increased, stimulating the release of a plasminogen activator. This therapy typically complements other prophylactic measures, such as antiembolic stockings and anticoagulants. Some exciting features include: - o User friendly master control unit that is designed so that its functions are self-explanatory - Power micro switch (ON/OFF) - . An alarm light displays a fault status with an audio alarm and LED display - . LED display that can monitor errors, sleeves statuses the device - User friendly hanging bracket that provides easy attachment The system consists of an air pump and single-patient-use compression sleeve one for the foot, one for the calf and one for the thigh. The air pump and compression sleeve may be used on one lower extremity. If the air pump is used simultaneously on both lower extremities, it is important that the identical sleeve type be used on both legs (i.e. foot sleeve with foot sleeve, calf sleeve with calf sleeve, or thigh sleeve with thigh sleeve). The inflation pressure settings are pre-set by the manufacturer and cannot be changed. The compression level for the foot sleeve is 120mmHg (16kPa). The compression level for the calf and thigh sleeve is 40mmHg. The sleeve inflates and maintains compression for 12 seconds. Then, the sleeve deflates for a period of 48 seconds. As the sleeve inflates, it compresses the foot, calf or thigh which augments venous blood flow, thereby reducing stasis. This process also stimulates fibrinolysis: thus, reducing the risk of early clot formation. Regularly check the system while in use, assuring pump operation and sleeve fit.
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    K Number
    K141064
    Device Name
    VESOFLOW PLUS DVT COMPRESSION DEVICE
    Manufacturer
    CAREMED SUPPLY, INC.
    Date Cleared
    2014-12-04

    (224 days)

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

    CAREMED SUPPLY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Caremed Supply Inc. VESOFLOW®PLUS SQS and IPCS Deep Vein Thrombosis (DVT) Compression Devices are intended to increase venous blood flow in at risk patients in order to help prevent deep vein thrombosis.
    Device Description
    VESOFLOW®PLUS that counteracts blood stasis and coagulation changes - two of the three major factors that promote deep vein thrombosis (DVT). VESOFLOW® PLUS is a non-invasive mechanical prophylactic system that massages the feet or legs in a wavelike, milking motion that promotes blood flow and deters thrombosis, helping to empty pooled or static blood from the valve cusps of the femoral vein. Fibrinolytic activity is increased, stimulating the release of a plasminogen activator. This therapy typically complements other prophylactic measures, such as antiembolic stockings and anticoagulants. VESOFLOW®PLUS is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb. Therefore, VESOFLOW®PLUS is identified as a compressible limb sleeve.
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    K Number
    K122873
    Device Name
    VASOPOUSE DEEP VEIN THROMBOSIS COMPRESSION DEVICE MODEL IPCS, MODEL SQS
    Manufacturer
    CAREMED SUPPLY, INC.
    Date Cleared
    2013-01-15

    (118 days)

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

    CAREMED SUPPLY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Caremed Supply Inc. VASOPOUSE® SQS and IPCS Decp Vein Thrombosis (DVT) Compression Devices are intended to increase venous blood flow in at risk patients in order to help prevent deep vein thrombosis.
    Device Description
    VASOPOUSE® that counteracts blood stasis and coagulation changes - two of the three major factors that promote deep vein thrombosis (DVT) - a potentially life threatening condition which can lead to pulmonary embolism. VASOPOUSE® is a non-invasive mechanical prophylactic system that massages the legs in a wavelike, milking motion that promotes blood flow and deters thrombosis, helping to empty pooled or static blood from the valve cusps of the femoral vein. Fibrinolytic activity is increased, stimulating the release of a plasminogen activator. This therapy typically complements other prophylactic measures, such as ant embolic stockings and anticoagulants. VASOPOUSE® is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb. Therefore, VASOPOUSE® is identified as a compressible limb sleve.
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    K Number
    K110977
    Device Name
    VESOFLOW
    Manufacturer
    CAREMED SUPPLY, INC.
    Date Cleared
    2011-08-25

    (140 days)

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

    CAREMED SUPPLY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Caremed Supply Inc. Vesoflow SQS and IPCS Deep Vein Thrombosis (DVT) Compression Devices are intended to increase venous blood flow in at risk patients in order to help prevent deep vein thrombosis.
    Device Description
    The Caremed Vesoflow® SQS and IPCS Deep Vein Thrombosis (DVT) Compression Systems are electrically powered, non-invasive mechanical compression devices designed for use by patients for whom external compression therapy is indicated. Their intended function and use is to increase venous blood flow and help prevent Deep Vein Thrombosis (DVT), by applying intermittent, controlled pressure to the calf, thigh or foot. The Vesoflow product will be available in two (2) models. These are the Vesoflow SQS and the Vesoflow IPCS. They differ in that the SQS delivers sequential compression therapy while the Vesoflow IPCS delivers intermittent compression therapy.
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