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510(k) Data Aggregation
K Number
K022340Device Name
TRAVELAIR PORTABLE COMPRESSION SYSTEM
Manufacturer
DYNAMIC AIR, INC.
Date Cleared
2003-02-19
(216 days)
Product Code
JOW
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
DYNAMIC AIR, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TravelAir Portable Compression System is intended to assist in the relief of the following: Fatigue in the lower limbs Venous congestion in the lower legs Edema in the lower legs Edema in the lower legs post injury or trauma Prevention of Deep Vein Thrombosis
Device Description
The Dynamic Air, Inc. TravelAir Portable Compression System consists of a battery operated compression pump connected to an inflatable leg wrap. The compression pump is connected to the leg wrap by plastic tubing connected by CPC quick connectors at the pump and at the tubing /wrap junction. The leg wrap consists of a Polyvinyl chloride (PVC) air bladder encapsulated inside a VelFoam material; the color of the outer covering material is white. The VelFoam material is adhered to the PVC air bladder. The wrap is provided clean, non-sterile packaged in pairs for use. The compression pump consists of a medical grade micro pump which delivers preset pressures to the leg wraps. The micro pump is controlled by a microchip controller board which regulates pressure and compression time on a set cycle. The compression pump inflates and deflates the leg wraps in a preset sequence intermittently compressing the soft tissue of the legs. This compression forces blood to move toward the heart and enhances venous return from the lower legs. After compression the wraps deflate and allow the veins and capillaries to refill. The cycle then repeats until the unit is deactivated.
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