510(k) · Cleared
ClearedGM3 Series HV Tens, Model GM3X3HV (Where X IS Parameter of Different Housing)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gemore Technology Co, Ltd. · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Cleared on Dec 16, 2003 as substantially equivalent to K946299 (Skylark Device Co., Ltd., 1995) after an 82-day review. Its family tree reaches back 1 generation to 1995. 7 later devices descend from it.
- Decided
- Dec 16, 2003
- Review
- 82 days
- Class
- Class II
- Product code
- GZJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K946299 (1995). 7 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK946299 PGS123 and HVS-123Skylark Device Co., Ltd. · 1995
- This deviceK032994 GM3 Series HV Tens, Model GM3X3HV (Where X IS Parameter of Different…Gemore Technology Co, Ltd. · 2003
- Descendant · cites it directly · 2 of its ownK071120 Aemed Stimpad Acu-Tens Transcutaneous Electrical Nerve Stimulator…Aemed, Inc. · 2008
- Descendant · cites it directly · 2 of its ownK042559 Gem-Twin Tens/ Models GM3XY/ZGemore Technology Co, Ltd. · 2004
- Descendant · 2 generations on · 0 of its ownK142686 StimPad OTCAemed, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK122948 Gem-Stim Combo StimulatorGemore Technology Co, Ltd. · 2012
- Descendant · 2 generations on · 0 of its ownK090866 Neurocalm Model 1 and 2Neuromed Devices, Inc. · 2009
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K071120Aemed Stimpad Acu-Tens Transcutaneous Electrical Nerve Stimulator, Model 021999Aemed, Inc. · 2008 · cites it directly2descendants
- K042559Gem-Twin Tens/ Models GM3XY/ZGemore Technology Co, Ltd. · 2004 · cites it directly2descendants
- K142686StimPad OTCAemed, Inc. · 2014 · 2 generations on0descendants
- K122948Gem-Stim Combo StimulatorGemore Technology Co, Ltd. · 2012 · 2 generations on0descendants
- K090866Neurocalm Model 1 and 2Neuromed Devices, Inc. · 2009 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K946299 | PGS123 and HVS-123 | Skylark Device Co., Ltd. | 1995 | — |
| 0 (this device) | K032994 | GM3 Series HV Tens, Model GM3X3HV (Where X IS Parameter of Different Housing) | Gemore Technology Co, Ltd. | 2003 | — |
| +1 | K071120 | Aemed Stimpad Acu-Tens Transcutaneous Electrical Nerve Stimulator, Model 021999 | Aemed, Inc. | 2008 | — |
| +1 | K042559 | Gem-Twin Tens/ Models GM3XY/Z | Gemore Technology Co, Ltd. | 2004 | — |
| +2 | K142686 | StimPad OTC | Aemed, Inc. | 2014 | — |
| +2 | K122948 | Gem-Stim Combo Stimulator | Gemore Technology Co, Ltd. | 2012 | — |
| +2 | K090866 | Neurocalm Model 1 and 2 | Neuromed Devices, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 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? (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 | Decided |
|---|---|---|---|
| * | K946299 | PGS123 and HVS-123Summary page 1…Voltage TENS Device / Model: GM3X3HV, where X is the parameter for different housing. 3. Information of the 510(k) Cleared Device (Predicate Device): PGS123 (k946299). 4. Device Description: The GM3X3HV is the device which generates twin high voltage pulses of electrical current. The… | 1995 |
What descends from it? (7)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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.
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?
The device is an high voltage TENS device with TENS indications used for
symptomatic relief and management of chronic intractable pain.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032994 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032994: GM3 Series HV Tens, Model GM3X3HV (Where X IS Parameter of Different Housing).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032994
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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