Jan 12, 2026
Most ViewedFDA approved VED's
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 device regulation
The FDA's treatment of Neuralink's implant as a Class III medical device and the company's obtaining of FDA clearance for human trials.
Fact-Checks
10 resultsJan 17, 2026
Most ViewedWhich vacuum erection devices appear in FDA 510(k) records and how to search the FDA database for cleared VEDs?
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...
Jan 19, 2026
Most ViewedHow do pressure limiters and safety features differ between medical‑grade and consumer penis pumps?
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...
Jan 14, 2026
How is hydrogen water regulated by the FDA, FTC, and equivalent agencies worldwide?
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...
Jan 30, 2026
Has Elon Musk ever filed patents related to medical devices or urology?
has been named on and associated with patent filings in technology areas that include s—most notably patents tied to ’s —so reporting supports that he has patent assets connected to implantable neurot...
Jan 18, 2026
How have AI‑generated doctor endorsements been used in health product marketing and what safeguards exist?
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...
Jan 17, 2026
How can consumers verify whether a specific penis pump model is FDA-cleared (510(k))?
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; ...
Jan 14, 2026
Are there any FDA recalls or safety warnings for vacuum erection devices?
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 ...
Jan 13, 2026
Which companies marketing 'medbeds' have received regulatory warnings or legal action and why?
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...
Jan 7, 2026
What ethical and regulatory safeguards exist for implantable neurotechnology trials in dementia patients?
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...