Which other manufacturers of vacuum erection devices have 510(k) clearances or FDA registrations?
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Executive summary
A small group of established companies market vacuum erection devices (VEDs) that claim FDA 510(k) clearance or FDA registration: Vacurect (Vacurect Manufacturing), Pos‑T‑Vac, Osbon/Timm Medical (ErecAid), and several legacy brands commonly listed by distributors such as SomaTherapy/August Medical and Encore Pumps; these names appear across FDA 510(k) records, vendor product pages, and industry guidance but public reporting and vendor pages do not supply a single, up‑to‑date FDA registry list to unequivocally confirm every claim [1] [2] [3] [4] [5] [6].
1. What the regulatory landscape actually requires: 510(k) vs. “FDA approved”
VEDs are Class II medical devices that generally enter the U.S. market through 510(k) premarket notification — manufacturers notify FDA their device is substantially equivalent to a predicate device — and the agency issues clearances rather than “approvals” for most VEDs; FDA guidance spells out design and safety expectations, including vacuum limits and safety valves [7] [8].
2. Names that recur in FDA documents and vendor claims
An explicit 510(k) summary exists for Vacurect Manufacturing (Vacurect), which appears in FDA documentation and lists product and company details [1]. Vendor and editorial sources repeatedly flag Pos‑T‑Vac as a long‑standing “medical‑grade” VED with FDA‑related claims [2] [9]. Osbon (Timm Medical/ErecAid) markets its ErecAid line as “FDA approved” on distributor sites and product pages, and is commonly cited alongside other established VED manufacturers [3] [10]. Distributor and retail listings also name brands such as Somatherapy/August Medical and Encore Pumps as leading, registered manufacturers [5] [6].
3. How to read vendor claims and why caution matters
Retail pages and manufacturer marketing routinely use shorthand—“FDA approved,” “FDA cleared,” or “medical‑grade”—but such language can blur the statutory distinction between registration/listing and 510(k) clearance; third‑party writeups and seller sites frequently assert FDA status without linking to the specific 510(k) number or FDA database entry, a gap that demands verification on the FDA’s own 510(k) and registration databases [5] [6] [7].
4. Conflicting signals and missing centralized confirmation
Industry observers note “only seven manufacturers” are registered as medical‑grade VED producers, a claim repeated on some trade sites yet not enumerated there, so while multiple sources converge on a short roster of names, none of the reporting provided produces a current, comprehensive FDA list that can be cited verbatim [6]. FDA’s 510(k) portal exists for exact checks, but the supplied materials here are a mix of primary FDA documents, distributor assertions, and secondary guidance rather than a single authoritative roster [7] [1] [5].
5. Alternative viewpoints and potential agendas
Manufacturers and distributors have clear commercial incentives to highlight “FDA” credentials because clearance or registration confers market legitimacy; consumer‑facing sites emphasize safety and clinical endorsements [2] [9], while independent clinical sources warn that non‑cleared “penis developers” sold online can expose users to unsafe pressures and lack FDA clearance [11]. That tension—between legitimate, cleared VEDs and unregulated consumer devices—drives divergent messaging in the marketplace [11] [6].
6. Practical next steps for verification
The reporting identifies likely manufacturers to start with—Vacurect, Pos‑T‑Vac, Osbon/ErecAid, SomaTherapy/August Medical, Encore Pumps—but the only way to confirm current 510(k) clearances or active FDA establishment registration is to search FDA’s 510(k) database and the FDA Establishment Registration & Device Listing database for each company and device model, because vendor pages and secondary articles do not substitute for the agency’s records [1] [7].