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510(k) Data Aggregation
K Number
K133119Device Name
FLOWTRON ACS800 PUMP AND TRI PULSE GARMENTS
Manufacturer
Date Cleared
2014-02-28
(151 days)
Product Code
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
ARJOHUNTLEIGH POLSKA SP Z.O.O.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
To help prevent Deep Vein Thrombosis (DVT)
Device Description
The Flowtron ACS800 pump 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 deep vein thrombosis.
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K Number
K122330Device Name
FLOWTRON FOOT GARMENT-REGULAR-STERILE FLOWTRON FOOT GARMENT-LARGE-STERILE
Manufacturer
Date Cleared
2012-12-07
(127 days)
Product Code
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
ARJOHUNTLEIGH POLSKA SP Z.O.O.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Prevention of Deep Vein Thrombosis (DVT)
Enhancement of venous & arterial circulation
Prevention of venous stasis
Assist healing of cutaneous ulcers
Reduction of acute or chronic edema
Reduction of lower limb pain due to surgery or trauma
Reduction of compartmental pressures
Device Description
The Flowtron Foot Garment is a wrap around foot garment comprising of a bladder and surrounding material intended to apply cyclic compression to the foot to improve return venous blood flow to prevent and reduce the risk of Deep Vein Thrombosis (DVT).
The Flowtron Foot Garment is connected to an ArjoHuntleigh Flowtron pneumatic pump. The pump controls and generated the delivery of air to inflate and deflate the Foot Garment in a cyclic manner.
Flowtron Foot Garments are configured with a custom design connector that means that they are only compatible with ArjoHuntleigh Flowtron pneumatic pumps.
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