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FDA Regulation of Vacuum Erection Devices

The FDA regulates vacuum erection devices, setting special controls for design features, labeling, and safety to mitigate injury risks.

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Jan 13, 2026
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What are the specific FDA‑cleared penis pumps and their safety features?

FDA classifies external penile rigidity devices — commonly called vacuum erection devices or penis pumps — as Class II medical devices and sets special controls that focus on specific design features ...