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510(k) Data Aggregation
K Number
K231801Device Name
MedHealth DVT compression Devices MHH900S/MHH900E
Manufacturer
Date Cleared
2023-12-14
(177 days)
Product Code
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
MedHealth Medical Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
MedHealth DVT Compression Devices MHH900S/MHH900E are intended to increase venous blood flow in at risk patients in order to help prevent deep vein thrombosis.
Device Description
The Deep Vein Thrombosis (DVT) Pumps MHH900S and MHH900E are external pneumatic compression (EPC) devices that aid in the prevention of DVT from a potentially life-threatening condition which can lead to pulmonary embolism. MHH900S and MHH900E are non-invasive mechanical prophylactic devices function as secondary pumps to propel venous blood for patients whose deep vein thrombosis must be prevented after surgeries in Orthopedics etc. Additionally, the devices are reusable and can be used for more than one patient within its lifecycle.
The two devices separately consist of an air pump and a soft pliable compression garment(s) (Purchased separately) for the foot, calf, or thigh. For MHH900S and MHH900E, the controller supplies compression on a preset timing cycle (12 seconds inflation and maintenance followed by 48 seconds of deflation) at a suggested pressure setting of 40 mmHg for the Leg and 120mmHg for the Foot. The pressure in the garments is transferred to the extremity, augmenting venous blood flow when the leg is compressed, reducing stasis. This process also stimulates fibrinolysis; thus, reducing the risk of early clot formation.
The DVT pumps produce automatically timed cycles of compressed air. This compressed air forces blood out of the deep veins, helping to prevent slowed or stopped blood flow. Bursts of air are delivered to the specially designed garments wrapped around extremities. This air helps to move blood out of the deep veins and reduce the risk of developing DVT.
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