Which VED models are FDA‑cleared and what specific safety features (e.g., pop‑off valves) do they list?
Executive summary
A narrow set of medical vendors and clinical resources repeatedly identify specific vacuum erection device (VED) models as “FDA‑cleared” — notably Augusta Medical’s SomaTherapy Manual and SomaTherapy Premium on menMD’s product and provider pages (menMD asserts these models are FDA‑approved/cleared) [1] [2] [3]. Independent clinical and regulatory guidance emphasizes the same safety design principle across cleared VEDs — a manual or automatic pressure‑release mechanism (often described as a pop‑off or safety release valve) to prevent excessive vacuum pressure — a feature explicitly noted by Mount Sinai and required in FDA Class II guidance [4] [5].
1. Which VED models are named as FDA‑cleared in the reporting
Commercial listings on menMD name the SomaTherapy Manual and SomaTherapy Premium by Augusta Medical as FDA‑cleared models and repeatedly counsel clinicians and patients to choose FDA‑cleared devices, framing those SomaTherapy units as examples [1] [3]. MenMD’s product page more broadly markets its VED offerings as “FDA‑cleared medical devices” for ED and post‑radical prostatectomy rehabilitation, but does not publish the FDA 510(k) numbers or a complete agency record in the excerpts provided [2]. A retail/supplier site (erecaidpumps.com) describes multiple branded systems — Erec‑Pro Plus, Revive Premium, and the EDP‑MAXRc — and lists pump heads described as having safety release valves, though the source mixes marketing claims and device descriptions without attaching definitive FDA‑clearance documentation in the snippets supplied [6]. A third party (Unlimited Manhood) asserts that “these are the only 3 VEDs cleared by the FDA,” but that specific claim appears unsupported by the other provided documents and lacks cited FDA entries in the excerpts [7].
2. What safety features do these sources list for FDA‑cleared VEDs
Clinical and regulatory sources converge on one core safety element: a mechanism to limit or rapidly release vacuum pressure. Mount Sinai states that FDA‑approved VEDs “have pop‑off valves to limit the amount of vacuum pressure,” explicitly linking that feature to reduced risk of penile injury [4]. The FDA’s Class II special controls guidance for external penile rigidity devices recommends a “manual safety mechanism — a vacuum device should include a manually operated mechanism to quickly release the vacuum pressure,” framing that design feature as a risk‑mitigating control manufacturers should include or otherwise justify [5]. Supplier descriptions corroborate this language in product terms, describing pump heads with “safety release valve” mechanisms or “patented Ring Ejector Sleeve System” intended to facilitate timely pressure release and ring removal [6].
3. Other safety recommendations and practical cautions cited
Beyond pop‑off valves and manual release mechanisms, clinical resources emphasize correct use: never leaving a constriction/tension ring on longer than recommended (commonly cited as 30 minutes), consulting a physician before use, and using medical‑grade devices rather than novelty pumps to avoid tissue damage — claims advanced by menMD, Mount Sinai and San Diego Sexual Medicine in the excerpts [3] [4] [8]. MenMD additionally stresses buying only FDA‑approved/cleared, medical‑grade devices and notes that improper or non‑medical devices can cause harm [1] [3].
4. Limits of the reporting and competing claims
The sources provided mix vendor marketing, clinical guidance and regulatory excerpts; none supplies a downloadable, authoritative FDA 510(k) list or the exact clearance numbers for every brand named, so a definitive, exhaustive roster of FDA‑cleared models cannot be compiled from these materials alone [2] [6] [7]. Some outlets assert a small number of cleared VEDs without documented FDA records in the excerpts [7], while vendor pages and suppliers present product‑level claims of clearance alongside device safety features [1] [2] [6]. The FDA guidance itself sets the standard — recommending manual or equivalent vacuum release mechanisms and other controls to minimize injury — but validation of any vendor’s “FDA‑cleared” claim requires checking the FDA 510(k) database for the specific model and submission number [5].
5. Bottom line for clinicians and patients
Reportedly FDA‑cleared VEDs that are named in these sources include Augusta Medical’s SomaTherapy Manual and SomaTherapy Premium as marketed by menMD, and supplier literature lists pump heads with safety release valves on systems such as Erec‑Pro variants; the consistent safety hallmark across clinical and regulatory sources is a pop‑off/safety release mechanism to limit vacuum pressure, with the FDA guidance explicitly recommending a manually operated quick‑release mechanism as a special control for Class II devices [1] [2] [6] [4] [5]. Because vendor marketing and secondary sites sometimes overstate clearance claims, direct verification against FDA 510(k) records is necessary to confirm clearance for any particular model — a step not documented in the provided excerpts [2] [7].