510(k) · Cleared

Cleared

Sterling Medical Impulse 3 Stimulator

K121305510(k) TraditionalCleared Sep 25, 2012147-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

Armstrong Industries, Inc. Dha Mediquip Int. Dha S · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief

Cleared on Sep 25, 2012 as substantially equivalent to K041388 (Biomedical Life Systems, Inc., 2004) and 3 other predicates after a 147-day review. Its family tree reaches back 2 generations to 1993.

Decided: Sep 25, 2012
Review: 147 days
Class: Class II
Product code: GZJ
Recalls: None
Predicates: 4

Its longest line of descent runs back 2 generations to K926510 (1993). 5 ancestors in all, the oldest K891118 (1989). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK926510 Staodyn Ems+2Staodyne, Inc. · 1993
1 generation backK041063 Smartwave MS 2000Newwave Medical, LLC · 2004
This deviceK121305 Sterling Medical Impulse 3 StimulatorArmstrong Industries, Inc. Dha Mediquip Int. Dha S · 2012

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K926510	Staodyn Ems+2	Staodyne, Inc.	1993	—
−1	K041063	Smartwave MS 2000	Newwave Medical, LLC	2004	—
0 (this device)	K121305	Sterling Medical Impulse 3 Stimulator	Armstrong Industries, Inc. Dha Mediquip Int. Dha S	2012	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1989	1	0
2001	1	0
2004	1	0

FIG. 1 — Lineage of K121305, 1993–2012Source: 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? (4)

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
*	K041388	Combination Powered Electrical Muscle Stimulator and Interferential Stimulator, Model… Summary page 1 …Manufacturer Device 510(k) Number Biomedical Life Systems, Inc. BMLS04-1 (QuadStar 11) K041388 Newwave Medical, LLC Smartwave IF 2000 K(003631 Newwave Medical, LLC…	Biomedical Life Systems, Inc.	2004	—
*	K003631	Smartwave IF 2000 Summary page 2 …vice -vdevice, de~vice 510(k) Number K121305 K0413B8 K041063 K891118 K003631 Device Name and Model Sterling Quad~tar I1 Smartwave MIS Sterling TENS Sma…	Newwave Medical, LLC	2001	—
*	K041063	Smartwave MS 2000 Summary page 1 …Newwave Medical, LLC Smartwave IF 2000 K(003631 Newwave Medical, LLC Smartwave MS 2000 K041063 Armstrong Industries, Inc. Sterling TENS K891118 Intended Use Statement The Impulse 3,…	Newwave Medical, LLC	2004	—
*	K891118	Sterling Tens Summary page 1 …Newwave Medical, LLC Smartwave MS 2000 K041063 Armstrong Industries, Inc. Sterling TENS K891118 Intended Use Statement The Impulse 3, when in interferential 5timulation (INF) mode, may be used for symptomatic relief and ma…	Armstrong Industries, Inc.	1989	—

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?

The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 11.3 years on median.
None of the 5 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. 2012, this device’s year, is highlighted.

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?

Interferential Stimulation (INF) is used for symptomatic relief and management of chronic (long-term) intractable pain and/or as an adjunctive treatment in the management of postsurgical and post-traumatic acute pain. External electrical neuromuscular stimulation (NMES) using biphasic output is indicated as therapeutic adjunct for: prevention or retardation of muscle disuse atrophy; relaxation of muscle spasm; muscle reeducation; maintaining and…

Read the full statement (112 words)

External electrical neuromuscular stimulation (NMES) using biphasic output is indicated as therapeutic adjunct for: prevention or retardation of muscle disuse atrophy; relaxation of muscle spasm; muscle reeducation; maintaining and increasing the range of motion; increasing local blood circulation and as immediate postsurgical stimulation of calf muscles to prevent venous thrombosis.

Transcutaneous Electrical Nerve Stimulation (TENS) is used for the symptomatic relief and management of chronic (long-term) intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain problems.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K121305 · printed Nov 6, 2026

Cite this page

510(k) Report. “K121305: Sterling Medical Impulse 3 Stimulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121305

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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