GWFClass II

Stimulator, Electrical, Evoked Response

21 CFR 882.1870 / Neurology

GWF is the FDA product code for Stimulator, Electrical, Evoked Response, a class II device type, regulated under 21 CFR 882.1870. As of 2026-09-10, FDA records hold 140 510(k) clearances under this code, the most recent dated 2026-06-27, and 16 recalls.

Classification record

Product code: GWF
Device name: Stimulator, Electrical, Evoked Response
Regulation: 21 CFR 882.1870
Device class: Class II
Review panel: Neurology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 141
Ingested recalls: 16

Clearances, product code GWF

By decision year

141 clearances under product code GWF with a decision year between 1978 and 2026, 1985 the highest year at 6.

Show the numbers

510(k) clearances under FDA product code GWF by decision year
Year	Clearances
1978	2
1981	3
1982	5
1983	2
1984	3
1985	6
1986	6
1987	5
1988	3
1989	4
1990	3
1991	4
1992	4
1993	5
1995	2
1996	4
1997	6
1998	4
1999	2
2000	5
2001	3
2002	1
2003	1
2004	4
2005	5
2006	4
2007	3
2008	2
2009	5
2010	3
2011	2
2012	4
2013	3
2014	1
2015	2
2016	1
2017	3
2019	1
2020	1
2021	2
2022	2
2023	2
2024	4
2025	1
2026	3

Applicants with the most clearances

Product code GWF

Applicants holding the most 510(k) clearances under product code GWF
Applicant	Clearances
Cadwell Laboratories, Inc.	12
Axon Systems, Inc.	7
Nihon Kohden America Inc	7
Excel Tech., Ltd.	6
Tracor Northern, Inc.	6
Bio-Logic Systems Corp.	5
Dantec Medical, Inc.	5
Medtronic, Inc.	5
NuVasive Inc	5
Tonica Elektronik a/S	5

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 80 companies shown, in name order