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510(k) Data Aggregation
K Number
K172103Device Name
Flowtron DVT5 Small Calf Garment
Manufacturer
Date Cleared
2018-03-02
(233 days)
Product Code
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
Getinge (Suzhou) Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
• To help prevent Deep Vein Thrombosis (DVT)
Device Description
The Flowtron Small Calf Garment is a wraparound Calf garment comprising of a bladder and surrounding material intended to apply cyclic compression to calf to improve return venous blood flow to prevent and reduce the risk of Deep Vein Thrombosis (DVT). The Flowtron Small Calf Garment is connected to an ArjoHuntleigh Flowtron pneumatic pump. The pump controls and generated the delivery of air to inflate and deflate the Calf Garment in a cyclic manner. Flowtron Calf Garments are configured with a custom design connector that means that they are only compatible with ArjoHuntleigh Flowtron pneumatic pumps
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K Number
K143438Device Name
Flowtron ACS900
Manufacturer
Date Cleared
2015-06-23
(203 days)
Product Code
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
Getinge (Suzhou) Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
To help prevent Deep Vein Thrombosis (DVT)
Device Description
The Flowtron ACS900 is a pneumatic pump that supplies compressed air to inflate compression garments that are attached to patient's limbs. It is designed to work with the ArjoHuntleigh ranges of DVT calf/thigh compression garments, Foot compression garments and Tri Pulse calf/thigh compression garments. The pump automatically senses the type of compression garment connected and adjusts the pressure/time cycle accordingly. Each garment is compressed alternately, applying pressure to the patient's limb to help prevent deen vein thrombosis.
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