510(k) · Cleared

Cleared

Stimate N601 Tens

K003487510(k) TraditionalCleared Jan 24, 200172-day reviewClass II21 CFR 882.5890

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Everyway Medical Instruments Co.,Ltd · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief

Cleared on Jan 24, 2001 after a 72-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 2 later devices descend from it.

Decided: Jan 24, 2001
Review: 72 days
Class: Class II
Product code: GZJ
Recalls: None
Predicates: 0

2 later devices descend from it, 1 citing it directly.

This deviceK003487 Stimate N601 TensEveryway Medical Instruments Co.,Ltd · 2001
Descendant · cites it directly · 1 of its ownK021794 Tatung TMD-26AX Series Tens, Models NO. TMD-26AB Tatung Tens (Blue…Tatung Co. · 2003
Descendant · 2 generations on · 0 of its ownK040311 Shian Jia Meei Digatal PWN Tens, Model YW-6000/UC-332/UC-330/ST-331Shian Jia Meei Enterprise Co., Ltd. · 2004

Most influential descendants

Showing 2 of 2 · See all

K021794Tatung TMD-26AX Series Tens, Models NO. TMD-26AB Tatung Tens (Blue Housing) TMD-26AY…Tatung Co. · 2003 · cites it directly1descendant
K040311Shian Jia Meei Digatal PWN Tens, Model YW-6000/UC-332/UC-330/ST-331Shian Jia Meei Enterprise Co., Ltd. · 2004 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K003487	Stimate N601 Tens	Everyway Medical Instruments Co.,Ltd	2001	—
+1	K021794	Tatung TMD-26AX Series Tens, Models NO. TMD-26AB Tatung Tens (Blue Housing)…	Tatung Co.	2003	—
+2	K040311	Shian Jia Meei Digatal PWN Tens, Model YW-6000/UC-332/UC-330/ST-331	Shian Jia Meei Enterprise Co., Ltd.	2004	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2004	1	0

FIG. 1 — Lineage of K003487, 2001–2004Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GZJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new GZJ device

#1 K252767 actiTENS miniscore 13.1 · 9 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K021794	Tatung TMD-26AX Series Tens, Models NO. TMD-26AB Tatung Tens (Blue Housing) TMD-26AY…	Tatung Co.	2003	1

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K021794 (Tatung Co., 2003) has gone furthest, with 1 descendant of its own.

How does its category compare?

All GZJ devices

GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GZJ

1in 2025

2007high 16 (2009) · low 1 (2023)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GZJ

207in 2024

2007high 344 (2014) · low 113 (2017)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GZJ

1in 2011

2007high 4 (2007) · low 0 (2009)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GZJ

13in 2025

2007high 58 (2017) · low 4 (2007)2025

MAUDE reports naming product code GZJ, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	13	223	4	4
2008	11	136	1	45
2009	16	155	0	17
2010	5	232	0	22
2011	5	168	1	22
2012	12	154	0	20
2013	2	—	0	10
2014	4	344	0	23
2015	3	202	0	18
2016	3	163	0	32
2017	3	113	0	58
2018	2	—	0	21
2019	3	156	0	7
2020	4	183	0	10
2021	3	231	0	5
2022	4	175	0	4
2023	1	—	0	39
2024	3	207	0	12
2025	1	—	0	13
2026	2	—	0	—

https://510kreport.com/device/K003487 · printed Nov 4, 2026

Cite this page

510(k) Report. “K003487: Stimate N601 Tens.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K003487

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026