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Regulation of vacuum erection devices by the FDA, including their classification, approval, and safety features.
Vacuum erection devices (penis pumps) are regulated medical devices in the U.S.; the FDA treats them as Class II external penile rigidity devices and has cleared many vacuum erection systems for the t...
Vacuum erection devices (VEDs), also known as vacuum constriction or “penis pump” devices, are regulated by the U.S. Food and Drug Administration as Class II medical devices — specifically falling und...
Vacuum erection devices (VEDs) are regulated as Class II medical devices and are most commonly cleared by the FDA through the 510(k) pathway rather than the stricter premarket approval (PMA) process, ...