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Device Safety Features

The safety features of vacuum erection devices, including pop-off/pressure-limit valves and quick-release mechanisms.

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Jan 17, 2026
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Which 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...

Feb 4, 2026

What are the signs of penile tissue damage from vacuum devices and when to seek urgent care?

can cause a range of injuries from superficial bruising and petechiae to severe ischemic damage, , loss of tissue and even impotence when misused or when nonmedical equipment is employed . Urgent care...