510(k) · Cleared

Cleared

Ttech Model 200E + Tens Device

K021436510(k) TraditionalCleared Jul 30, 200285-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

Theratech, Inc. · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief

Cleared on Jul 30, 2002 as substantially equivalent to K002874 (Well-Life Consultant, 2001) after an 85-day review. Its family tree reaches back 1 generation to 2001. 1 later device descends from it.

Decided: Jul 30, 2002
Review: 85 days
Class: Class II
Product code: GZJ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K002874 (2001). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK002874 Well-TensWell-Life Consultant · 2001
This deviceK021436 Ttech Model 200E + Tens DeviceTheratech, Inc. · 2002
Descendant · cites it directly · 0 of its ownK073438 Prostim 1000/2000Bio Protech, Inc. · 2008

Most influential descendants

Showing 1 of 1 · See all

K073438Prostim 1000/2000Bio Protech, Inc. · 2008 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K002874	Well-Tens	Well-Life Consultant	2001	—
0 (this device)	K021436	Ttech Model 200E + Tens Device	Theratech, Inc.	2002	—
+1	K073438	Prostim 1000/2000	Bio Protech, Inc.	2008	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0

FIG. 1 — Lineage of K021436, 2001–2008Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and 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

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K002874	Well-Tens Summary page 1 …e Summary Prepared: Contact: Ms. Tammy McGarr 2. Name of the Device: Ttech Model 200E + TENS Device 3. Predicate Device Information: K# 002874/S002, Well-TENS, Model WL-2103A, Well-Life Healthcare Inc. 4. Device Description: The Ttech 200E + TENS Device is a…	Well-Life Consultant	2001	—

Also cleared against K002874: 3 other devices →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K073438	Prostim 1000/2000	Bio Protech, Inc.	2008	0

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?

Its one ancestor has no recall.
Of its descendants, K073438 (Bio Protech, Inc., 2008) has gone furthest, with 0 descendants of its own.
3 other devices also cite its predicate K002874.

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 Ttech Model 200E + TENS Device is intended for symptomatic relief of chronic intractable pain.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K021436 · printed Nov 4, 2026

Cite this page

510(k) Report. “K021436: Ttech Model 200E + Tens Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021436

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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