A device intended to be applied externally to the penis for the management of erectile dysfunction (ED) (commonly known as impotence) by enabling the maintenance of a penile erection adequate for vaginal intercourse. It is typically designed as a flexible rubb
| Company | Devices | Share |
|---|---|---|
| Blush Novelties | 120 | 79% |
| Giddy Holdings, Inc. | 12 | 8% |
| Leloi Ab | 8 | 5% |
| Kessel Medintim Gmbh | 5 | 3% |
| Augusta Medical Systems, L.L.C. | 3 | 2% |
| Fun Factory Gmbh | 2 | 1% |
| Rb Health (Us) Llc | 1 | 1% |
Company = labeler of record on GUDID. 7 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 | 150 |
| LKY | Device, external penile rigidity | 1 |
Use these as the dimensions to specify in a tender line.
151 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Penile ring", from 7 companies. The largest labeler is Blush Novelties with 79% 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.
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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.