Data / Medical devices / Stimulator, Neuromuscular, External Functional / United States
FDA-registered makers of Stimulator, Neuromuscular, External Functional in the United States: 13 establishments
13 establishments in the United States are registered with the FDA to make Stimulator, Neuromuscular, External Functional (product code GZI). 8 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 2, 2026.
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- Device
- Stimulator, Neuromuscular, External Functional
- Product code
- GZI
- Country
- United States
Makers of Stimulator, Neuromuscular, External Functional in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Bioness Medical, Inc. | Valencia, CA, United States | Complaint file establishment, Manufacturer | 6 | March 4, 2020 | 0 | 0 | 0 | api.fda.gov |
| CIONIC Facility | Scotts Valley, CA, United States | Manufacturer, Remanufacturer, Repackager or relabeler, Specification developer | 3 | May 2, 2025 | 0 | 0 | 0 | api.fda.gov |
| Innovative Neurotronics Inc. | Reno, NV, United States | Manufacturer, Specification developer | 3 | August 8, 2014 | 0 | 1 | 0 | api.fda.gov |
| Restorative Therapies Inc. | Nottingham, MD, United States | Manufacturer | 3 | July 11, 2017 | 0 | 0 | 0 | api.fda.gov |
| Myolyn, Inc | Gainesville, FL, United States | Manufacturer | 2 | April 25, 2022 | 0 | 1 | 0 | api.fda.gov |
| Evolution Devices, Inc. | San Francisco, CA, United States | Specification developer | 1 | December 28, 2023 | 0 | 0 | 0 | api.fda.gov |
| Neuvotion, Inc. | Stamford, CT, United States | Specification developer | 1 | November 22, 2024 | 0 | 0 | 0 | api.fda.gov |
| Synapse Biomedical Inc. | Oberlin, OH, United States | Complaint file establishment, Manufacturer | 1 | June 5, 2025 | 0 | 0 | 0 | api.fda.gov |
| Amrex-Zetron, Inc. | Paramount, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bioventus LLC | Cordova, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Clearlake-Tech Inc | Clear Lake, SD, United States | Contract manufacturer, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Djo, LLC | Carlsbad, CA, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Drive Northpoint, LLC | Palmetto, GA, United States | Manufacturer | 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.