510(k) · Cleared
ClearedStimOnTM Pain Relief System (GM2439)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gimer Medical Co., Ltd. · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Cleared on Aug 26, 2022 as substantially equivalent to K081835 (Bioinduction Limited, 2009) and 1 other predicate after a 263-day review. Its family tree reaches back 5 generations to 1988.
- Decided
- Aug 26, 2022
- Review
- 263 days
- Class
- Class II
- Product code
- GZJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K882438 (1988). 21 ancestors in all, the oldest K872657 (1987). No later device cites it as a predicate yet.
- Root · 5 generations backK882438 Constant Current Peripheral Nerve Stim. #NS252Fisher & Paykel Healthcare, Ltd. · 1988
- 4 generations backK023342 Neuro-Trace Iii Kit, Neuro-Trace Iii Regional Block Cable…Hdc Corp. · 2004
- 3 generations backK072092 Xpod/Xmap Nerve StimulatorXavant Technology (Pty), Ltd. · 2007
- 2 generations backK093591 Stimpod Model NMS-400 Nerve StimulatorXavant Technology (Pty), Ltd. · 2009
- 1 generation backK161091 STIMPOD NMS460 Nerve StimulatorXavant Technology (Pty), Ltd. · 2017
- This deviceK213802 StimOnTM Pain Relief System (GM2439)Gimer Medical Co., Ltd. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K882438 | Constant Current Peripheral Nerve Stim. #NS252 | Fisher & Paykel Healthcare, Ltd. | 1988 | — |
| −4 | K023342 | Neuro-Trace Iii Kit, Neuro-Trace Iii Regional Block Cable, Neuro-Trace Iii… | Hdc Corp. | 2004 | — |
| −3 | K072092 | Xpod/Xmap Nerve Stimulator | Xavant Technology (Pty), Ltd. | 2007 | — |
| −2 | K093591 | Stimpod Model NMS-400 Nerve Stimulator | Xavant Technology (Pty), Ltd. | 2009 | — |
| −1 | K161091 | STIMPOD NMS460 Nerve Stimulator | Xavant Technology (Pty), Ltd. | 2017 | — |
| 0 (this device) | K213802 | StimOnTM Pain Relief System (GM2439) | Gimer Medical Co., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K081835 | Acticare IC and TseSummary page 4…CFR Part 882.5890 Device Class II Classification Panel Neurology 3 Primary Predicate Device 510(k) number: K081835 Trade or proprietary or Bioinduction Acticare HFT/HFI… | 2009 |
| * | K161091 | STIMPOD NMS460 Nerve StimulatorSummary page 5…Telephone number: +44 117 377 5275, Fax number: +44 117 377 5405) Secondary Predicate Device 510(k) number: K161091 Trade or proprietary or STIMPOD NMS460 Nerve Stimulator model name: XAVANT T… | 2017 |
| † | K180865 | ZMI Self-Adhesive Electrodes | 2018 |
| † | K180943 | BioWaveGO | 2018 |
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 34 years and passes through 4 companies; a new generation was cleared every 5.6 years on median.
- None of the 21 ancestors has a recall.
- 1 other device also cites its predicate K081835.
How does its category compare?
All GZJ devicesGZJ Stimulator, Nerve, Transcutaneous, For Pain Relief: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · GZJ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GZJ
207in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GZJ
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GZJ
13in 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?
StimOnTm Pain Relief System (GM2439) is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical or post-traumatic pain.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213802 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213802: StimOnTM Pain Relief System (GM2439).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213802
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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