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510(k) Data Aggregation
K Number
K112838Device Name
VASOPRESS REPROCESSED DVT LEG / FOOT GARMENTS
Manufacturer
Date Cleared
2011-11-10
(43 days)
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
COMPRESSION THERAPY CONCEPTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The DVT Garment is an external pneumatic compression device intended to lower the risk of deep vein thrombosis (DVT) and resulting pulmonary embolism (PE) in patients who may be at risk for thrombosis formation.
Device Description
The VasoPress Reprocessed DVT Leg Garment consists of a brushed nylon outer material bonded to a foam inner liner bonded to a tricot lining. An inflatable polyvinylchloride (PVC) pressure bag is encapsulated between an additional nylon/foam material. The VasoPress Reprocessed DVT Foot Garment has the same outer shell with a polyurethane (PU) pressure bag inside. An exit tube leads out from the pressure bag for connection to the VasoPress Pump. The device is automatically inflated by a pneumatic pump. The patient contact material is tricot over polyurethane foam. The reprocessed devices are cleaned, inspected and tested, packaged and exposed to Ethylene Oxide (EO) gas wash. The VasoPress Reprocessed DVT Garments are provided non-sterile.
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K Number
K101915Device Name
VASOPRESS SUPREME MINI MODEL VP500DM
Manufacturer
Date Cleared
2010-08-06
(28 days)
Product Code
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
COMPRESSION THERAPY CONCEPTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The VasoPress Pump (Model VP500DM) is an external pneumatic compression device for use with VasoPress DVT garments, and is intended to lower the risk of deep vein thrombosis (DVT) in patients who may be at risk.
Device Description
VasoPress DVT Supreme Mini, Pump Model No. VP500DM
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K Number
K061814Device Name
VASOPRESS DVT SYSTEM, MODEL VP500D
Manufacturer
Date Cleared
2006-11-30
(156 days)
Product Code
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
COMPRESSION THERAPY CONCEPTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The VasoPress pump (VP500D) is an external pneumatic compression device for use with VasoPress DVT garments, and is intended to lower the risk of deep vein thrombosis (DVT) in patients who may be at risk.
Device Description
VasoPress DVT System, Pump Model VP500D
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K Number
K061967Device Name
SCD GARMENT, MODEL VP530
Manufacturer
Date Cleared
2006-09-25
(75 days)
Product Code
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
COMPRESSION THERAPY CONCEPTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The VasoQuential is designed to increase venous blood flow in at The Vasoquencear in order to help prevent Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE).
Device Description
Not Found
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K Number
K000147Device Name
CTC DVT-1 CALF GARMENT, MODEL DVT-1
Manufacturer
Date Cleared
2000-04-13
(86 days)
Product Code
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
COMPRESSION THERAPY CONCEPTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K961621Device Name
THERAPY CONCEPTS WATER CIRCULATING TREATMENT SYSTEM
Manufacturer
Date Cleared
1996-10-31
(188 days)
Product Code
Regulation Number
890.5720Why did this record match?
Applicant Name (Manufacturer) :
THERAPY CONCEPTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Therapy Concepts Water Circulating Treatment System will be used to pump chilled or room temperature water through a plastic pad that is placed on a mattress underneath the user and in so doing, will provide cold temperature therapy intended to temporarily assist in the localized reduction of minor swelling and pain. Pre-chilled water will be provided by adding ice cubes and water to the reservoir. The cooling rate is adjusted by adjusting the rate of flow of the water through the plastic pad.
Device Description
The Therapy Concepts Water Circulating Treatment System will consist of five discreet modules. A reservoir module holding 1.5 liters of water. A low voltage DC pump with integral connection tubing. A wall mounted power supply to provide 7,5 volts DC to power the pump. A plastic/foam pad with connecting tubing, containing channels through which water is circulated and a form fitted sewn nylon carrying case.
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