GZJClass II

Stimulator, Nerve, Transcutaneous, For Pain Relief

21 CFR 882.5890 / Neurology

GZJ is the FDA product code for Stimulator, Nerve, Transcutaneous, For Pain Relief, a class II device type, regulated under 21 CFR 882.5890. As of 2026-09-10, FDA records hold 606 510(k) clearances under this code, the most recent dated 2026-05-28, and 7 recalls.

Classification record

Product code: GZJ
Device name: Stimulator, Nerve, Transcutaneous, For Pain Relief
Regulation: 21 CFR 882.5890
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: 606
Ingested recalls: 7

Clearances, product code GZJ

By decision year

606 clearances under product code GZJ with a decision year between 1976 and 2026, 1991 the highest year at 38.

Show the numbers

510(k) clearances under FDA product code GZJ by decision year
Year	Clearances
1976	1
1977	3
1978	10
1979	13
1980	13
1981	15
1982	17
1983	26
1984	22
1985	25
1986	26
1987	31
1988	23
1989	22
1990	17
1991	38
1992	15
1993	12
1994	16
1995	8
1996	10
1997	13
1998	11
1999	10
2000	5
2001	20
2002	27
2003	22
2004	15
2005	7
2006	13
2007	13
2008	11
2009	16
2010	5
2011	5
2012	12
2013	2
2014	4
2015	3
2016	3
2017	3
2018	2
2019	3
2020	4
2021	3
2022	4
2023	1
2024	3
2025	1
2026	2

Applicants with the most clearances

Product code GZJ

Applicants holding the most 510(k) clearances under product code GZJ
Applicant	Clearances
BioMedical Life Systems Inc.	22
Medical Devices Inc.	16
American Imex	11
Bio-Medical Research, Ltd.	10
Henley Intl.	10
Medtronic, Inc.	10
Skylark Device Co., Ltd.	10
Apex Medical, Inc.	8
Monad Corp.	8
Well-Life Healthcare Limited	8

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 179 companies shown, in name order