510(k) · Cleared

Cleared

Duomed, Series 500, (Models ID 500, FL 500)

K030140510(k) TraditionalCleared Mar 18, 200363-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

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

Cleared on Mar 18, 2003 as substantially equivalent to K924876 (Graham-Field, Inc., 1994) and 1 other predicate after a 63-day review. Its family tree reaches back 1 generation to 1994.

Decided: Mar 18, 2003
Review: 63 days
Class: Class II
Product code: GZJ
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K924876 (1994). 2 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK924876 Tens Device for Relief of Chronic Pain, ModifiedGraham-Field, Inc. · 1994
This deviceK030140 Duomed, Series 500, (Models ID 500, FL 500)Duomed, Inc. · 2003

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K924876	Tens Device for Relief of Chronic Pain, Modified	Graham-Field, Inc.	1994	—
0 (this device)	K030140	Duomed, Series 500, (Models ID 500, FL 500)	Duomed, Inc.	2003	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0

FIG. 1 — Lineage of K030140, 1994–2003Source: 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

Get a 510(k) Report

What was it cleared against? (2)

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
*	K924876	Tens Device for Relief of Chronic Pain, Modified Summary page 1 …competitive products. IX. Substantial Equivalence: It is equivalent to several devices but especially to the Graham-Field TENS Plus device cleared under K924876, and the Yoram device cleared under KO02297 to which it is nearly identical. The "51O(k) Substantial Equivalence Decis…	Graham-Field, Inc.	1994	—
*	K002297	Yoramed, Model T-202	United Yoram Distributors, Inc.	2001	—

What descends from it?

No later submission names this one as a predicate yet.

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?

None of the 2 ancestors has a recall.

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?

Indicated for the symptomatic relief and management of chronic (long term) intractable pain

and/or as an adjunct treatment in the management of post-surgical and post-traumatic

acute pain.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K030140 · printed Nov 4, 2026

Cite this page

510(k) Report. “K030140: Duomed, Series 500, (Models ID 500, FL 500).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K030140

Report an extraction error

Are you the manufacturer?

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