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510(k) Data Aggregation
K Number
K241096Device Name
Venera 608 Deep Vein Thrombosis (DVT) Prevention System
Manufacturer
Suzhou Minhua Medical Apparatus Supplies Co., Ltd
Date Cleared
2025-01-15
(268 days)
Product Code
JOW
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
Suzhou Minhua Medical Apparatus Supplies Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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
K233276Device Name
Reusable Blood Pressure Cuff
Manufacturer
Suzhou Minhua Medical Apparatus Supplies Co., LTD
Date Cleared
2023-12-21
(83 days)
Product Code
DXQ, DXO
Regulation Number
870.1120Why did this record match?
Applicant Name (Manufacturer) :
Suzhou Minhua Medical Apparatus Supplies Co., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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
K171889Device Name
Reusable Blood Pressure Cuff
Manufacturer
Suzhou Minhua Medical Apparatus Supplies Co., LTD
Date Cleared
2017-12-19
(176 days)
Product Code
DXQ, DXO
Regulation Number
870.1120Why did this record match?
Applicant Name (Manufacturer) :
Suzhou Minhua Medical Apparatus Supplies Co., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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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