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Imagyn Medical

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Feb 1, 2026

Which vacuum erection devices are FDA‑cleared and what warranty/support do major manufacturers offer?

A range of vacuum erection devices (VEDs) are marketed as -cleared or FDA-registered medical devices, but regulatory nuance matters: many VEDs are cleared via 510(k) pathways or are listed on FDA/GUDI...

Jan 12, 2026

Which vacuum erection devices have FDA 510(k) clearances and what do their 510(k) summaries say?

A small set of commercially marketed vacuum erection devices (VEDs) hold FDA 510(k)-era clearances or are registered in federal device databases, but public documentation varies: Imagyn Medical’s Irnp...

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Imagyn Medical

Fact-Checks

Which vacuum erection devices are FDA‑cleared and what warranty/support do major manufacturers offer?

Which vacuum erection devices have FDA 510(k) clearances and what do their 510(k) summaries say?