A device that is applied externally to the penis for the management of erectile dysfunction (ED) (commonly known as impotence) to achieve selective penile tumescence and rigidity adequate for vaginal intercourse. It is typically a two-component device consisti
| Company | Devices | Share |
|---|---|---|
| Pos-T-Vac Inc | 84 | 28% |
| Dx Products Limited | 48 | 16% |
| Encore, Inc. | 44 | 15% |
| Augusta Medical Systems, L.L.C. | 43 | 14% |
| Pd Products, Llc | 21 | 7% |
| Blush Novelties | 12 | 4% |
| Gesiva Medical Llc | 12 | 4% |
| Dr. Joel Kaplan, Inc. | 10 | 3% |
| Owen Mumford Usa Incorporated | 9 | 3% |
| Reach Medical, Inc. | 6 | 2% |
| Dolanvy (Suzhou) Medical Technology Co.,Ltd. | 2 | 1% |
| Kessel Medintim Gmbh | 2 | 1% |
Company = labeler of record on GUDID. 15 companies in total; top 12 shown. Click headers to sort.
Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.
| Code | Name | Devices |
|---|---|---|
| LKY | Device, External Penile Rigidity | 277 |
| LKY | Device, external penile rigidity | 2 |
Use these as the dimensions to specify in a tender line.
298 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Penile vacuum device", from 15 companies. The largest labeler is Pos-T-Vac Inc with 28% of records.
LKY (Device, External Penile Rigidity), LKY (Device, external penile rigidity)
No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.
Add penile vacuum device to the RFQ basket or use the form below with quantity, specification and delivery location; the Network returns comparable quotes from verified suppliers in 2–5 working days.
Hospitals, pharmacies and distributors anywhere: tell us what you need and the Consulting Wallah Network returns comparable quotes from verified suppliers. No fee for buyers.
Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.