Data / Medical devices / Stimulator, Electrical, Non-Implantable, For Incontinence / United States
FDA-registered makers of Stimulator, Electrical, Non-Implantable, For Incontinence in the United States: 12 establishments
12 establishments in the United States are registered with the FDA to make Stimulator, Electrical, Non-Implantable, For Incontinence (product code KPI). 12 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 3, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Device
- Stimulator, Electrical, Non-Implantable, For Incontinence
- Product code
- KPI
- Country
- United States
Makers of Stimulator, Electrical, Non-Implantable, For Incontinence in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Incontrol Medical, LLC | Pewaukee, WI, United States | Manufacturer | 5 | March 15, 2019 | 0 | 0 | 0 | api.fda.gov |
| Laborie Medical Technologies Corp. | Portsmouth, NH, United States | Manufacturer, Specification developer | 4 | May 4, 2007 | 0 | 0 | 0 | api.fda.gov |
| Djo, LLC | Carlsbad, CA, United States | Specification developer | 3 | November 3, 1998 | 0 | 0 | 0 | api.fda.gov |
| The Prometheus Group | Dover, NH, United States | Manufacturer | 3 | May 23, 2003 | 0 | 0 | 0 | api.fda.gov |
| Axion Usa LLC | Carteret, NJ, United States | Repackager or relabeler, Specification developer | 2 | February 12, 2026 | 0 | 0 | 0 | api.fda.gov |
| Relevium Labs, Incorporated | Oxford, OH, United States | Specification developer | 2 | May 4, 2016 | 0 | 0 | 0 | api.fda.gov |
| Utah Medical Products, Inc. | Midvale, UT, United States | Manufacturer | 2 | February 10, 1997 | 0 | 0 | 0 | api.fda.gov |
| Amarigo Inc | Los Angeles, CA, United States | Manufacturer | 1 | November 27, 2024 | 0 | 0 | 0 | api.fda.gov |
| Altivera Medical, Inc. | Englewood, CO, United States | Manufacturer | 1 | August 24, 2012 | 0 | 0 | 0 | api.fda.gov |
| Med-Linket Corp | Alhambra, CA, United States | Manufacturer | 1 | September 17, 2021 | 0 | 0 | 0 | api.fda.gov |
| REACT Innovations | Charlotte, NC, United States | Manufacturer | 1 | June 12, 1998 | 0 | 0 | 0 | api.fda.gov |
| Trinity Medical Solutions, LLC | Homewood, AL, United States | Manufacturer | 1 | August 29, 2025 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 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.