List of brands and models of VEDs that are registered with the FDA
Executive summary
A targeted review of the provided reporting identifies several brands and specific models of vacuum erection devices (VEDs) that are described as FDA-cleared, FDA-registered, or cleared via 510(k) filings, including Vacurect, Pos‑T‑Vac (Erect Vac Max MVP), SomaTherapy (Manual and Premium), Osbon/ErecAid (Esteem), and an Imppower/Impower System listed in an FDA 510(k) summary [1] [2] [3] [4] [5] [6] [7]. The documentation also shows that VEDs are class II devices subject to FDA guidance and import alert monitoring, but the sources provided do not constitute a comprehensive FDA registry to confirm every model or its specific 510(k) number [8] [7].
1. Brands and models named in the reporting
Multiple sources name devices marketed as FDA‑cleared or FDA‑registered: Vacurect is repeatedly marketed as FDA/CE approved and an OTC VED with a “Deluxe” model referenced (Vacurect™ and Vacurect 1002‑OTC) [2] [1], Pos‑T‑Vac appears across patient‑facing outlets and reviews with models such as the Pos‑T‑Vac Erect Vac Max MVP and the Erect Vac Max series [3] [4], Augusta Medical’s SomaTherapy Manual and SomaTherapy Premium models are listed as FDA‑approved in product cataloging [5], and Timm Medical/Osbon’s ErecAid Esteem/manual and battery variants (Erec‑Vac, EDP systems) are described as compliant with FDA requirements in vendor catalogs [6]. An actual FDA 510(k) summary in the file set names Imagyn Medical Technologies’ Impower System (vacuum erection system) as the subject of a 510(k) clearance document (k020969), which is direct evidence of FDA clearance for that specific submission [7].
2. What the regulatory paper trail in these sources shows
The presence of a 510(k) summary (Imagyn/Impower System) is concrete regulatory evidence that at least one VED received FDA clearance through premarket notification [7], and vendor and clinical resources repeatedly assert that selected devices are “FDA‑cleared,” “FDA‑approved,” or “FDA‑registered” [5] [1] [2]. The FDA’s regulatory framework treats vacuum pumps and constriction rings as Class II devices governed by special controls, and the agency’s import alert and guidance documents explicitly categorize these products and set expectations for compliance [8]. Clinical and institutional pages (Mount Sinai, MedlinePlus, Center for Male Reproductive Medicine) also note that FDA‑approved VEDs exist and describe safety features (pop‑off valves, constriction ring time limits) that are characteristic of regulated devices [9] [10] [11].
3. Conflicting claims, marketing spin and gaps in verification
Marketing copy on vendor and manufacturer sites sometimes uses terms like “FDA approved,” “meets FDA standards,” or “FDA registered” interchangeably, and those claims appear in Vacurect and other vendor pages without a consistently cited 510(k) number for each model [2] [1] [4]. Independent clinical summaries and institutional guidance caution that many internet‑available pumps are not FDA‑approved and recommend clinician guidance before purchase, underscoring a mismatch between marketing and verified regulatory status for every product listed online [9]. The reporting set lacks a comprehensive crosswalk to the FDA’s own searchable 510(k) database for each named model, so definitive confirmation of clearance for every branded model named here cannot be established from these sources alone [7] [8].
4. Practical takeaway and how to verify beyond these sources
From the documentation provided, readers can reasonably treat Vacurect (Deluxe/1002‑OTC), Pos‑T‑Vac series (Erect Vac Max MVP), SomaTherapy Manual and Premium, Osbon/ErecAid Esteem and related EDP models, and the Imagyn Impower System as brands and models represented in the market with claims of FDA clearance or registration in the sources reviewed [1] [2] [3] [4] [5] [6] [7]; however, formal verification requires checking the FDA’s 510(k) and device registration databases for the exact model numbers and corresponding clearance numbers, because marketing language on vendor sites can overstate or conflate regulatory status [8] [7] [9]. The FDA import alert and guidance pages confirm that vacuum pumps and constriction rings are regulated categories that should be subject to Class II controls, offering the official framework for any independent verification effort [8].