Which vacuum erection devices (VEDs) are currently registered with the FDA?
Executive summary
A small set of vacuum erection devices (VEDs) appear in the supplied reporting as either FDA-registered/cleared or described by vendors and clinicians as “FDA-approved” or “FDA-cleared,” most prominently the Vacurect system (documented in an FDA 510(k) summary and the GUDID entry) and several commercial lines that claim FDA clearance such as SomaTherapy (Augusta Medical), POS‑T‑VAC, and Vitality’s OTC systems; independent confirmation beyond the supplied sources is limited by the scope of the reporting [1] [2] [3] [4] [5].
1. Vacurect: the device tied to an actual FDA 510(k) summary and a GUDID record
Vacurect is the clearest example in the material: an FDA 510(k) summary is included in the results discussing a Vacuum Constriction Device and the device’s eligibility to be marketed under general controls (which implies FDA review) [1], and the National Library of Medicine’s AccessGUDID database has an entry for the Vacurect device describing the product contents and listing details consistent with a registered medical device [2].
2. Vendor claims and marketing: Vacurect repeated across company sites and resellers
Multiple vendor pages and reseller listings identify Vacurect as “FDA-registered” or meeting FDA over‑the‑counter standards—claims repeated on manufacturer and retail pages that describe the Vacurect as an FDA-registered VED, OTC-capable, and widely marketed for ED and penile rehabilitation [6] [7] [8]. These are vendor assertions that align with the presence of a 510(k) summary and GUDID record cited above [1] [2].
3. Other named devices: SomaTherapy (Augusta Medical) and retailer statements
MenMD’s product and provider pages list SomaTherapy Manual and SomaTherapy Premium models by Augusta Medical among “FDA-cleared” options and present them as clinically tested VEDs suitable for ED and post‑prostatectomy rehabilitation [9] [3]. Those pages are commercial/clinic sources asserting FDA clearance for specific models, which the supplied reporting cites as vendor statements rather than separate FDA documentation [3] [9].
4. POS‑T‑VAC and Vitality: commercial claims of FDA approval in retailer copy
POS‑T‑VAC products and Vitality-branded OTC premium systems are described on retailer and product pages as “FDA-approved” or “FDA-approved pumps” and as OTC solutions for ED [4] [5]. These snippets document marketing claims that the devices meet FDA standards, but the supplied material does not include direct FDA database records or 510(k) summaries for POS‑T‑VAC or Vitality to independently verify those claims [4] [5].
5. Clinical and institutional context: FDA approval exists as a general statement for VEDs, but specifics matter
Clinical resources and encyclopedic pages note that vacuum erection devices have been FDA‑approved for ED management and describe safety features clinicians look for—pop‑off valves and vacuum limiters—while advising prescription or clinician guidance because many internet-sold pumps are not FDA‑approved [10] [11] [12]. Those sources establish that FDA‑cleared VEDs exist but do not enumerate all registered models; they caution that not all commercially available pumps meet FDA standards [10] [11].
6. What can and cannot be concluded from the assembled reporting
From the provided documents, Vacurect is documented with the strongest FDA trail—a 510(k) summary reference and a GUDID device record [1] [2]—while SomaTherapy, POS‑T‑VAC and Vitality systems are presented in vendor/retailer material as FDA‑cleared or FDA‑approved [3] [9] [4] [5]. The reporting does not include the full FDA device registration listings for every manufacturer nor explicit 510(k) numbers or FDA database screenshots for every named product, so a definitive, exhaustive list of “all currently registered VEDs” cannot be compiled from these sources alone [1] [2] [3].
7. Practical next steps to verify registration status
To produce a complete, authoritative list, the FDA’s public databases (e.g., 510(k) database and GUDID/AccessGUDID) should be queried for each manufacturer and product model cited by vendors; the supplied material gives clear leads—Vacurect’s 510(k) summary and GUDID entry and vendor model names like SomaTherapy, POS‑T‑VAC and Vitality OTC—that can be used to locate those official records [1] [2] [3] [4] [5]. Until those database queries are performed, the best-supported conclusion from the supplied reporting is that Vacurect is demonstrably registered/cleared, and several other commercial VED lines claim FDA clearance in vendor materials but lack corroborating FDA documentation in the provided snippets [1] [2] [3] [4] [5].