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The FDA regulates devices that create or maintain penile rigidity, including vacuum pumps, constriction rings, and splints, under Class II special controls.
The FDA separates devices that create or maintain penile rigidity (vacuum pumps, constriction rings, splints) from products marketed as penile enlargement or treatments for penile curvature; the forme...
FDA‑regulated external penile rigidity devices — commonly called medical penis pumps or vacuum erection devices (VEDs) — are governed by Class II special controls that prescribe specific safety featur...