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    K Number
    K173528
    Device Name
    Devon 24R Deep Vein Thrombosis (DVT) Prevention Therapy System
    Manufacturer
    Devon Medical Products (Jiangsu) Ltd.
    Date Cleared
    2018-02-06

    (83 days)

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

    Devon Medical Products (Jiangsu) Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Devon 24R deep vein thrombosis prevention system is intended to be an easy to use portable system, prescribed by a physician, to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (simulating muscle contractions). This device can be used in the home or clinical settings to: · Aid in the prevention of DVT - · Enhance blood circulation - · Diminish post-operative pain and swelling - · Reduce wound healing time · Aid in the treatment of: stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs · As a prophylaxis for DVT by persons expecting to be stationary for long periods of time
    Device Description
    Not Found
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    K Number
    K172030
    Device Name
    Devon 51
    Manufacturer
    Devon Medical Products (Jiangsu) Ltd.
    Date Cleared
    2017-11-27

    (145 days)

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

    Devon Medical Products (Jiangsu) Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Devon 51 Series Sequential Compression Device is a compression device based on sequential pneumatic Compression technique which is intended for the treatment of the following conditions: - Lymphedema - Venous stasis ulcers - Venous insufficiency - Peripheral edema The device is intended for both home and hospital use.
    Device Description
    The Devon 51 Sequential Compression device is a gradient compression pneumatic device used for treatment and management of venous or lymphatic disorders. The application of gradient compression is effective by increasing blood flow and encouraging extracellular fluid clearance. The system consists of a pump and a pair of four-chambered garments. The garments are available in different types and sizes. The pump provides cycles of compressed air at certain adjustable pressures and which sequentially inflates the garment from distal to proximal. When activated, air flows into the garment chambers, and the pump provides gradient pressurization to the chambers (with distal chambers inflated to a greater pressure than the proximal ones.) After each chamber is inflated, the pressure is held constant until all chambers are inflated in order to prevent reverse gradient flow. Once all chambers are inflated, they are then all released simultaneously, and the cycle repeats until the set therapy time is reached.
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    K Number
    K170814
    Device Name
    Devon 24
    Manufacturer
    Devon Medical Products (Jiangsu) Ltd.
    Date Cleared
    2017-07-11

    (116 days)

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

    Devon Medical Products (Jiangsu) Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Devon 24 deep vein thrombosis prevention system is intended to be an easy to use portable by a physician, to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (simulating muscle contractions). This device can be used in the home or clinical settings to: - · Aid in the prevention of DVT - · Enhance blood circulation - · Diminish post-operative pain and swelling - · Reduce wound healing time · Aid in the treatment of: stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs · As a prophylaxis for DVT by persons expecting to be stationary for long periods of time
    Device Description
    The Devon 24 deep vein thrombosis prevention therapy system (referred as Devon 24 below) is an easy to use portable pneumatic compression system that noninvasively helps prevent the onset of DVT in patients by stimulating blood flow in the extremities (simulating muscle contractions). The Devon 24 system consists of a pair of pumps and sleeve assemblies. The device will alternatively inflate and deflate the garment (sleeve) to stimulate blood flow in the extremities (muscle contraction). The device provides a 40mmHg pressure and followed by a deflation period once it reaches the desired pressure, each cycle time is 50 seconds.
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