510(k) · Cleared

Cleared

Limited Function WL/Otc-Tens Device, Model WL-2103A, WL-2203A, WL-2203B and WL-2401

K040512510(k) TraditionalCleared May 27, 200490-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

Well-Life Healthcare, Inc. · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief

Cleared on May 27, 2004 after a 90-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 82 later devices descend from it.

Decided: May 27, 2004
Review: 90 days
Class: Class II
Product code: GZJ
Recalls: None
Predicates: 0

82 later devices descend from it, 4 citing it directly.

This deviceK040512 Limited Function WL/Otc-Tens Device, Model WL-2103A, WL-2203A…Well-Life Healthcare, Inc. · 2004
Descendant · cites it directly · 58 of its ownK112392 Hivox Biotek Inc.Hivox Biotek, Inc. · 2012
Descendant · 2 generations on · 55 of its ownK122744 Prospera Otc Tens Electronic Pulse MassagerProspera Corporation · 2013
Descendant · 3 generations on · 26 of its ownK133929 Health Expert Elctronic StimulatorShenzhen Osto Technology Company Limited · 2014
Descendant · 3 generations on · 17 of its ownK143207 Revitive IX (OTC)Actegy, Ltd. · 2015
Descendant · cites it directly · 14 of its ownK060222 Low Back Pain Relief System /Models GM310PP,GM320PP,GM321PP, and…Gemore Technology Co, Ltd. · 2006

Showing 5 of 82 descendants. See all descendants

Descendants cleared per year

2006high 9 (2015) · low 0 (2008)2026

Most influential descendants

Showing 5 of 82 · See all

K112392Hivox Biotek Inc.Hivox Biotek, Inc. · 2012 · cites it directly58descendants
K122744Prospera Otc Tens Electronic Pulse MassagerProspera Corporation · 2013 · 2 generations on55descendants
K133929Health Expert Elctronic StimulatorShenzhen Osto Technology Company Limited · 2014 · 3 generations on26descendants
K143207Revitive IX (OTC)Actegy, Ltd. · 2015 · 3 generations on17descendants
K060222Low Back Pain Relief System /Models GM310PP,GM320PP,GM321PP, and GM330PPGemore Technology Co, Ltd. · 2006 · cites it directly14descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K040512	Limited Function WL/Otc-Tens Device, Model WL-2103A, WL-2203A, WL-2203B and…	Well-Life Healthcare, Inc.	2004	—
+1	K112392	Hivox Biotek Inc.	Hivox Biotek, Inc.	2012	—
+2	K122744	Prospera Otc Tens Electronic Pulse Massager	Prospera Corporation	2013	—
+3	K133929	Health Expert Elctronic Stimulator	Shenzhen Osto Technology Company Limited	2014	—
+3	K143207	Revitive IX (OTC)	Actegy, Ltd.	2015	—
+1	K060222	Low Back Pain Relief System /Models GM310PP,GM320PP,GM321PP, and GM330PP	Gemore Technology Co, Ltd.	2006	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	2	0
2007	1	0
2009	1	0
2011	2	0
2012	3	0
2013	5	0
2014	5	0
2015	9	0
2016	3	0
2017	6	0
2018	6	0
2019	7	0
2020	4	0
2021	9	0
2022	4	0
2023	4	0
2024	6	0
2025	3	0
2026	2	0

FIG. 1 — Lineage of K040512, 2004–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), 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’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (82)

See all 82

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K112392	Hivox Biotek Inc.	Hivox Biotek, Inc.	2012	58
K060222	Low Back Pain Relief System /Models GM310PP,GM320PP,GM321PP, and GM330PP	Gemore Technology Co, Ltd.	2006	14
K052785	Otc Tens for Low Back Pain Relief, Model WL-2405 and WL-2406	Well-Life Healthcare Limited	2006	8
K063660	Otc Tens for Low Back Pain Relief, Model WL-2407	Well-Life Healthcare Limited	2007	3

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, K112392 (Hivox Biotek, Inc., 2012) has gone furthest, with 58 descendants 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	—

What is it indicated for?

The model WL-2402, WL-2403 TENS are intended for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities.

The model WL-2401 TENS is indicated for use in the relief of nausea and vomiting due to motion sickness, and for the relief of mild to moderate nausea and vomiting associated with pregnancy.

Indications for use as stated in the FDA 510(k) statement.

https://510kreport.com/device/K040512 · printed Nov 3, 2026

Cite this page

510(k) Report. “K040512: Limited Function WL/Otc-Tens Device, Model WL-2103A, WL-2203A, WL-2203B and WL-2401.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040512

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026