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510(k) Data Aggregation

    K Number
    K241096
    Device Name
    Venera 608 Deep Vein Thrombosis (DVT) Prevention System
    Date Cleared
    2025-01-15

    (268 days)

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

    Suzhou Minhua Medical Apparatus Supplies Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Venera 608 Series system is a prescription device intended to be used preventatively to increase venous blood flow in patients at risk of deep vein thrombosis due to the associated risk factors for thrombus formation during: trauma, critical care, general medicine, general surgery, as well as neurological, orthopedic, urologic, obstetric conditions and treatments.
    Device Description
    The Venera™ 608 Series deep vein thrombosis prevention system is a pneumatic compression device that noninvasively helps reduce the incidence of deep vein thrombosis, a potentially life-threatening condition. The Venera™ 608 Series system consists of a device and a pair of soft compression cuff(s) (sleeves) and the extension tubing set for the calf, calf-thigh, and foot. The device will alternatively inflate the two cuffs and mimic the natural walking pace in order to enhance circulation. The device-supplied compression provides a 60-second automatically timed cycle consisting of an approximately 12-second inflation period followed by a 48-second period of relaxation. A pressure of 40mmHg is used for the calf, calf-thigh, and 120mmHg for foot treatments. This pressurization enhances venous flow and fibrinolytic activity in order to ultimately prevent early blood clotting.
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    K Number
    K233276
    Device Name
    Reusable Blood Pressure Cuff
    Date Cleared
    2023-12-21

    (83 days)

    Product Code
    Regulation Number
    870.1120
    Why did this record match?
    Applicant Name (Manufacturer) :

    Suzhou Minhua Medical Apparatus Supplies Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Reusable Blood Pressure Cuff is an accessory used in conjunction with non-invasive blood pressure measurement systems. The cuff is non-sterile and reusable. It is available in adult size.
    Device Description
    The proposed device is an accessory used in conjunction with non-invasive blood pressure measurement systems, and wrap around the patient's limb. The cuff is non-sterile and reusable. The model difference of the proposed device includes bladder type, tube, color, joint model and size.
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    K Number
    K180389
    Device Name
    Venera 508 Deep Vein Thrombosis (DVT) Prevention System
    Date Cleared
    2018-06-29

    (136 days)

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

    Suzhou Minhua Medical Apparatus Supplies Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Venera 508 Deep Vein Thrombosis (DVT) Prevention Therapy System is a portable treatment to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (simulating muscle contractions). This system can be applied in either 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 Venera™ 508 Deep Vein Thrombosis Prevention System is an easy to use portable pneumatic compression system that noninvasively helps prevent the onset of DVT in patients by simulating blood flow in the extremities (simulating muscle contractions). The Venera 508 system consists of a pair of pump and cuff assemblies. The device will alternatively inflate and deflate the garment (cuff) to stimulate blood flow in the extremities (muscle contraction). The device provides a 50mmHg pressure and followed by 50 seconds of deflation period once it reaches the desired pressure.
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    K Number
    K171889
    Device Name
    Reusable Blood Pressure Cuff
    Date Cleared
    2017-12-19

    (176 days)

    Product Code
    Regulation Number
    870.1120
    Why did this record match?
    Applicant Name (Manufacturer) :

    Suzhou Minhua Medical Apparatus Supplies Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Reusable Blood Pressure Cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is non-sterile and reusable in infant, pediatric but not neonatal, and adult sizes.
    Device Description
    The proposed device is an accessory used in conjunction with noninvasive blood pressure measurement systems, and wrap around the patient's limb. The cuff is non-sterile and reusable. The model difference of the proposed device includes bladder type, tube, color, joint model and size.
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    K Number
    K143728
    Device Name
    Minhua Disposable Blood Pressure Cuff
    Date Cleared
    2015-05-15

    (137 days)

    Product Code
    Regulation Number
    870.1120
    Why did this record match?
    Applicant Name (Manufacturer) :

    SUZHOU MINHUA MEDICAL APPARATUS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Minhua Disposable Blood Pressure Cuff is an accessory used in conjunction with non-invasive blood pressure monitoring systems for determination of a person's blood pressure. The cuff is non-sterile and for single-patient use. It is available in neonatal, pediatric and adult sizes. The cuff is not designed, sold, or intended for use except as indicated.
    Device Description
    The device comprises tubing attached to an inelastic sleeve with an integrated inflatable bladder that is wrapped around the patient's limb, secured by hook and loop closure, and used to measure the patient's blood pressure. The device tubing is connected to a non-invasive blood pressure measurement system.
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