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Federal Agents Seize FastSize Extenders and FastSize EQM™ Erectile Quality Monitors
Date:7/27/2010

Unapproved devices are adulterated and misbranded; safety and efficacy not established

SILVER SPRING, Md., July 27 /PRNewswire-USNewswire/ -- At the request of the U.S. Food and Drug Administration, U.S. Marshals today seized $346,954.43 worth of FastSize Extender devices and FastSize EQM™ Erectile Quality Monitor devices, as well as component parts used in the manufacture of the FastSize Extender. The FastSize Extender and the FastSize EQM™ Erectile Quality Monitor are manufactured and distributed by FastSize, LLC of Aliso Viejo, Calif.

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The FastSize Extender and the FastSize EQM™ Erectile Quality Monitor are misbranded and adulterated because they, among other things, are unapproved and were manufactured under conditions that did not meet current Good Manufacturing Practices (cGMP) requirements. The seizure warrant was issued by the U.S. District Court for the Central District of California.

The FastSize EQM™ Erectile Quality Monitor device was promoted to measure penile axial rigidity (inte
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SOURCE U.S. Food and Drug Administration
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