510(k) · Cleared
ClearedGem-Stim Tens, Models GM3XY and GM3AXY
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 10, 2003 as substantially equivalent to K021359 (Well-Life Healthcare, Inc., 2002) and 1 other predicate after a 99-day review. Its family tree reaches back 1 generation to 2002. 4 later devices descend from it.
- Decided
- Dec 10, 2003
- Review
- 99 days
- Class
- Class II
- Product code
- GZJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K021359 (2002). 2 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK021359 Digi-Pro Tens Model WL-2203 and WL-2205Well-Life Healthcare, Inc. · 2002
- This deviceK032720 Gem-Stim Tens, Models GM3XY and GM3AXYGemore Technology Co, Ltd. · 2003
- 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 ownK122948 Gem-Stim Combo StimulatorGemore Technology Co, Ltd. · 2012
- Descendant · 2 generations on · 0 of its ownK082057 DX6605E-Tens, DX6605E-G, DX6609-GShenzhen Dongdixin Technology Co., Ltd. · 2009
- Descendant · cites it directly · 0 of its ownK082377 Tenscare Itouch Model (S) Easy and PlusTenscare, Ltd. · 2009
Most influential descendants
Showing 4 of 4 · See all- K042559Gem-Twin Tens/ Models GM3XY/ZGemore Technology Co, Ltd. · 2004 · cites it directly2descendants
- K122948Gem-Stim Combo StimulatorGemore Technology Co, Ltd. · 2012 · 2 generations on0descendants
- K082057DX6605E-Tens, DX6605E-G, DX6609-GShenzhen Dongdixin Technology Co., Ltd. · 2009 · 2 generations on0descendants
- K082377Tenscare Itouch Model (S) Easy and PlusTenscare, Ltd. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K021359 | Digi-Pro Tens Model WL-2203 and WL-2205 | Well-Life Healthcare, Inc. | 2002 | — |
| 0 (this device) | K032720 | Gem-Stim Tens, Models GM3XY and GM3AXY | Gemore Technology Co, Ltd. | 2003 | — |
| +1 | K042559 | Gem-Twin Tens/ Models GM3XY/Z | Gemore Technology Co, Ltd. | 2004 | — |
| +2 | K122948 | Gem-Stim Combo Stimulator | Gemore Technology Co, Ltd. | 2012 | — |
| +2 | K082057 | DX6605E-Tens, DX6605E-G, DX6609-G | Shenzhen Dongdixin Technology Co., Ltd. | 2009 | — |
| +1 | K082377 | Tenscare Itouch Model (S) Easy and Plus | Tenscare, Ltd. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2009 | 2 | 0 |
| 2012 | 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 |
|---|---|---|---|
| * | K021359 | Digi-Pro Tens Model WL-2203 and WL-2205Summary page 1…ent operation type, which may be different with the parameter of "0T", "0E", "0PP", "0PE", and "OTE". 3. Information of the 510(k) Cleared Device (Predicate Device): K021359 & K020314. 4. Device Description: The GEM-STIM TENS series, including GM3XOT/GM3AXOT, GM3XOE/GM3AXOE, GM3XOPP/GM3AXOPP,… | 2002 |
| * | K020314 | Digi-Pro Tens, Model WL-2204 and WL-2205Summary page 1…ion type, which may be different with the parameter of "0T", "0E", "0PP", "0PE", and "OTE". 3. Information of the 510(k) Cleared Device (Predicate Device): K021359 & K020314. 4. Device Description: The GEM-STIM TENS series, including GM3XOT/GM3AXOT, GM3XOE/GM3AXOE, GM3XOPP/GM3AXOPP, GM3XOPE/G… | 2002 |
What descends from it? (4)
2 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?
This device is a prescription device and only for symptomatic relief of chronic intractable pain.
* Relaxation of muscle spasms.
* Prevention or retardation of disuse atrophy.
* Increasing local blood circulation.
* Muscle re-education.
* Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
* Maintaining or increasing range of motion.
· Relaxation of muscle spasms.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032720 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032720: Gem-Stim Tens, Models GM3XY and GM3AXY.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032720
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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