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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

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.

The provided text is a 510(k) summary for the "TravelAir Portable Compression System." It describes the device, its intended use, and its substantial equivalence to predicate devices. However, the document does not contain a study that provides acceptance criteria and performance data for the device.

Instead, it states:

• "Bench testing performed by Dynamic Air has show that the leg wraps are substantially equivalent in performance to the predicate devices."
• "Bench testing and side by side comparisons were done with predicate devices to assure equivalence in performance."
• "There are no performance standards for this class of medical device (class II)."

This indicates that the submission relied on demonstrating equivalence through bench testing against predicate devices rather than establishing novel performance criteria or conducting a clinical study to prove adherence to such criteria.

Therefore, I cannot populate the requested table or sections because the information is not present in the provided document. The 510(k) summary focuses on demonstrating substantial equivalence, not conducting a performance study with specific acceptance criteria and results.

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