Data / Medical devices / Device, External Penile Rigidity / United States
FDA-registered makers of Device, External Penile Rigidity in the United States: 16 establishments
16 establishments in the United States are registered with the FDA to make Device, External Penile Rigidity (product code LKY). 0 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Device, External Penile Rigidity
- Product code
- LKY
- Country
- United States
Makers of Device, External Penile Rigidity in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Augusta Medical Systems, LLC | Augusta, GA, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Djo, LLC | Carlsbad, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DR Joel Kaplan Inc | San Diego, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dri View | Shepherdsville, KY, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Encore, Inc. | Sarasota, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| FFX Inc. | Hopkins, MN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Firmtech Inc. | Bozeman, MT, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Giddy Holdings, Inc. | Austin, TX, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Molded Products Inc. | Harlan, IA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pathright Medical,,inc. | Orem, UT, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pos-T-Vac, LLC | Dodge City, KS, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| R.A.D. Group | Racine, WI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Reach Medical, Inc. | Collierville, TN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| RP Therapies | Saint Joseph, LA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| RX Sleeve | Upland, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vee International Inc. | Garden City, NY, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.