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The Elite Custom consists of a manual vacuum pump, a cylinder, cushion inserts, constriction ring loader, constriction rings, and lubricant. The Elite Custom's intended use is to manage erectile dysfunction by allowing the creation of a full erection suitable for sexual activity. This is accomplished through the use of the manual vacuum pump to remove air from the cylinder, creating vacuum pressure within the cylinder. Blood is thereby drawn into the penis, causing it to become erect. The constriction ring is then placed around the base of the erect penis to restrict the outflow of blood. When activity is complete, the ring is removed from the base of the + penis.

This product is intended for prescription use.

The Elite Custom consists of a manual vacuum pump, a cylinder, cushion inserts, constriction ring loader, constriction rings, and lubricant.

I am sorry. This document is a letter from the FDA to a medical device manufacturer, indicating that their device, the "Elite Custom™ Vacuum Erection Device," has been found substantially equivalent to legally marketed predicate devices. It discusses regulatory compliance and marketing permissions. This type of document does not contain information about acceptance criteria or specific studies detailing device performance metrics. Therefore, I cannot provide the requested information based on the given text.

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