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FDA classifies external penile rigidity devices under Class II special controls
Vacuum erection devices (VEDs) appear in FDA records as Class II external penile rigidity devices with manufacturers and specific models documented in 510(k) summaries and complementary registries; na...
Vacuum erection devices (VEDs) are an established, FDA‑regulated class of medical devices used to treat erectile dysfunction and for penile rehabilitation; the FDA has classified them as Class II devi...
Medical‑grade vacuum erection devices (VEDs) are designed to meet FDA Class II controls and typically include engineered pressure limiters, automatic and manual vacuum release mechanisms, and electric...
AI‑generated doctor endorsements have become a new marketing tool for health products, with synthetic physician images and quotes used to imply medical authority while often skirting explicit clinical...
Verifying whether a specific penis pump (vacuum erection device) model is FDA-cleared via the 510(k) pathway requires a mix of document checks, database searches, and scrutiny of manufacturer claims; ...
Hydrogen gas dissolved in beverages has been deemed Generally Recognized as Safe (GRAS) by the U.S. FDA for use in drinks up to a specified concentration, but that GRAS status governs safety as a food...
There are no explicit, documentable FDA recalls for vacuum erection devices (VEDs) in the material provided here, but the FDA has issued device-specific guidance and safety labeling expectations that ...
There is clear evidence that U.S. regulators are stepping up enforcement against misleading medical and health product marketing, including issuing “cease and desist” letters and scrutinizing fine det...
Trials of implantable neurotechnology in dementia sit at the intersection of established medical-device regulation, research ethics for impaired populations, and novel risks from AI-driven brain inter...