Data / Medical devices / Stimulator, Electrical, Evoked Response
Stimulator, Electrical, Evoked Response (GWF): 73 FDA-registered makers in 17 countries
73 establishments in 17 countries are registered with the FDA to make Stimulator, Electrical, Evoked Response (product code GWF, Class 2, 21 CFR 882.1870). 27 of them have a 510(k) clearance or PMA approval on file and 6 have a recall event. The FDA has issued 141 510(k) clearances under this code, the latest on September 24, 2026, and lists 13 recall events (1 Class I). FDA data exported November 2, 2026.
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- Product code
- GWF
- Device class
- 2
- Regulation
- 882.1870
- Medical specialty
- Neurology
Makers by country
| Country | Makers |
|---|---|
| United States | 47 |
| Japan | 4 |
| Germany | 3 |
| China | 3 |
| Denmark | 2 |
| United Kingdom | 2 |
| Netherlands | 2 |
| Russia | 1 |
| Finland | 1 |
| Italy | 1 |
| Canada | 1 |
| Ireland | 1 |
| Israel | 1 |
| Costa Rica | 1 |
| Australia | 1 |
| Dominican Republic | 1 |
| Poland | 1 |
Makers of Stimulator, Electrical, Evoked Response
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Natus Neurology Incorporated | Middleton, WI, United States | Manufacturer, Specification developer | 6 | January 22, 2025 | 0 | 0 | 0 | api.fda.gov |
| Tonica Elektronik A/S | FARUM Hovedstaden, Denmark | Contract manufacturer, Manufacturer | 6 | March 31, 2017 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Xomed, Inc. | Jacksonville, FL, United States | Manufacturer | 5 | October 28, 2020 | 0 | 4 | 1 | api.fda.gov |
| Alphatec Spine, Inc. | Carlsbad, CA, United States | Manufacturer, Specification developer | 4 | January 11, 2026 | 0 | 1 | 0 | api.fda.gov |
| Alphatec Spine, Inc. | Memphis, TN, United States | Manufacturer | 4 | January 11, 2026 | 0 | 0 | 0 | api.fda.gov |
| Globus Medical, Inc. | Memphis, TN, United States | Manufacturer | 4 | May 14, 2010 | 0 | 0 | 0 | api.fda.gov |
| Inomed Medizintechnik GMBH | EMMENDINGEN Baden-Wurttemberg, Germany | Manufacturer | 4 | September 24, 2026 | 0 | 0 | 0 | api.fda.gov |
| Nihon Kohden America, Inc. | Irvine, CA, United States | Complaint file establishment, Manufacturer | 4 | April 24, 2015 | 0 | 2 | 0 | api.fda.gov |
| Nihon Kohden Corp. | SHINJUKU-KU Tokyo, Japan | Specification developer | 4 | April 24, 2015 | 0 | 0 | 0 | api.fda.gov |
| Nihon Kohden Tomioka Production Center | TOMIOKA-SHI Gunma, Japan | Manufacturer | 4 | April 24, 2015 | 0 | 0 | 0 | api.fda.gov |
| Nuvasive, Inc. | San Diego, CA, United States | Manufacturer | 4 | May 14, 2010 | 0 | 0 | 0 | api.fda.gov |
| Nihon Kohden Corporation - Tokorozawa establishment Advanced Technology Center | Tokorozawa Saitama, Japan | Complaint file establishment, Specification developer | 4 | April 24, 2015 | 0 | 0 | 0 | api.fda.gov |
| Nihon Kohden Tomioka Corporation | Gunma Tokyo, Japan | Manufacturer | 4 | April 24, 2015 | 0 | 0 | 0 | api.fda.gov |
| The Magstim Company Ltd. | Carmarthenshire Wales, United Kingdom | Complaint file establishment, Manufacturer | 4 | August 23, 2013 | 0 | 0 | 0 | api.fda.gov |
| Cadwell Industries, Inc. | Kennewick, WA, United States | Manufacturer, Specification developer | 2 | August 17, 2023 | 0 | 3 | 0 | api.fda.gov |
| Digitimer Ltd. | Welwyn Garden City Hertfordshire, United Kingdom | Manufacturer | 2 | September 20, 2005 | 0 | 0 | 0 | api.fda.gov |
| Neurosoft Ltd | Ivanovo Ivanovskaya Oblast', Russia | Manufacturer | 2 | August 13, 2021 | 0 | 0 | 0 | api.fda.gov |
| Nexstim Plc | Helsinki Uusimaa, Finland | Manufacturer | 2 | May 22, 2012 | 0 | 1 | 0 | api.fda.gov |
| Soterix Medical,inc. | Woodbridge, NJ, United States | Manufacturer | 2 | March 25, 2024 | 0 | 0 | 0 | api.fda.gov |
| Computational Diagnostics, Inc. | Oakland, PA, United States | Manufacturer, Repackager or relabeler, Specification developer | 1 | January 26, 1996 | 0 | 0 | 0 | api.fda.gov |
| Eb Neuro S.P.A. | Arbizzano di Valpolicella Verona, Italy | Manufacturer | 1 | August 19, 2015 | 0 | 0 | 0 | api.fda.gov |
| Laborie Medical Technologies Corp. | Portsmouth, NH, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 1 | March 3, 2004 | 0 | 0 | 0 | api.fda.gov |
| LKC Technologies, Inc. | Germantown, MD, United States | Manufacturer | 1 | March 4, 1982 | 0 | 0 | 0 | api.fda.gov |
| Natus Medical Incorporated Dba Excel-Tech Ltd. (xltek) | OAKVILLE Ontario, Canada | Complaint file establishment, Specification developer | 1 | August 11, 2010 | 0 | 1 | 0 | api.fda.gov |
| Neurovision Medical Products, Inc. | Ventura, CA, United States | Manufacturer | 1 | April 5, 2017 | 0 | 0 | 0 | api.fda.gov |
| Natus Manufacturing Limited | GORT, Co. Galway(County), Ireland | Contract manufacturer, Manufacturer | 1 | December 12, 2024 | 0 | 0 | 0 | api.fda.gov |
| Nihon Kohden America Fulfillment Center | Foothill Ranch, CA, United States | Manufacturer | 1 | August 17, 2005 | 0 | 0 | 0 | api.fda.gov |
| 3D MEDICAL MANUFACTURING, INC. (dba Tecomet) | Riviera Beach, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ad-Tech Medical Instrument Corp. | Oak Creek, WI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alpha Omega Engineering Ltd. | Nof HaGalil Northern, Israel | Complaint file establishment, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ARCH Medical Solutions - Memphis | Bartlett, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ARCH Medical Solutions - Memphis | Lexington, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ARCH Medical Solutions - Olive Branch | Olive Branch, MS, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ARCH Medical Solutions - Seabrook | Seabrook, NH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ATL Technology CR Limitada | Alajuela, Costa Rica | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Avalign Instruments & Implants | Fort Wayne, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Brain Science Tools BV | De Bilt Utrecht, Netherlands | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cirtec Medical | Brooklyn Park, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Compumedics Limited | Melbourne Victoria, Australia | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Culver Tool & Engineering | Plymouth, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Covidien | - Santo Domingo, Dominican Republic | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Demcon Production B.V. | Enschede Overijssel, Netherlands | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ducommun LaBarge Technologies | Appleton, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eemagine Medical Imaging Solutions GMBH | Berlin, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Exxelia Micropen | Honeoye Falls, NY, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Engineered Medical Systems, LLC | Bartlett, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ferry Machine Corporation | Oakland, NJ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fideltronik Poland SP. Z O.O. | Sucha Beskidzka Malopolskie, Poland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ferry Machine Corporation | Little Ferry, NJ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Graphic Controls Acquisition Corp.dba Nissha Medical Technologies | Buffalo, NY, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hipp Medical AG | Renquishausen Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Insert Molding Solutions, Inc. | Cumming, GA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Intelligent Hearing Systems Corp. | Miami, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Life Science Outsourcing, Inc. | Brea, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mackay Manufacturing, Inc. | Spokane Valley, WA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Magnus Medical Inc. | Burlingame, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medtronic Sofamor Danek Usa, Inc. | Memphis, TN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medtronic Sofamor Danek Usa, Inc. | Memphis, TN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| NGInstruments, Inc dba Avalign Cutting Instruments | Warsaw, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nuvasive, Inc. | Guaynabo, PR, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Onyx Healthcare Usa, Inc. | Orange, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paul E. Danchell A/S | Jyderup Sjaelland, Denmark | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Remington Medical, Inc. | Alpharetta, GA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| RMS Co. | Minneapolis, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Remington Medical, Inc. | Alpharetta, GA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shandong Weigao Orthopaedic Device Co.,ltd | weihai Shandong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Launch Electrical Co., Ltd | Shenzhen Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Structure Medical, LLC. | Naples, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Spartronics Watertown LLC | Watertown, SD, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Turner Medical Inc. | Athens, AL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tegra Medical | Hernando, MS, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Warsaw Orthopedic, Inc. | Warsaw, IN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xian Friendship Medical Electronics Co., Ltd. | Xi'an Shaanxi, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated September 24, 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.