510(k) · Cleared
ClearedGem-Stim Combo Stimulator
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 21, 2012 as substantially equivalent to K042559 (Gemore Technology Co, Ltd., 2004) after an 88-day review. Its family tree reaches back 4 generations to 1992.
- Decided
- Dec 21, 2012
- Review
- 88 days
- Class
- Class II
- Product code
- GZJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K921441 (1992). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK921441 Interferential Stimulator Model Inf 4150/aBiomedical Life Systems, Inc. · 1992
- 3 generations backK952683 Apex Medical Corp. Portable Interferential Stimulation DeviceWholesale Medical Imports, Inc. · 1997
- 2 generations backK032719 GM3 Series IF Tens, Model GM3X2IF (Where X IS a Parameter of…Gemore Technology Co, Ltd. · 2003
- 1 generation backK042559 Gem-Twin Tens/ Models GM3XY/ZGemore Technology Co, Ltd. · 2004
- This deviceK122948 Gem-Stim Combo StimulatorGemore Technology Co, Ltd. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K921441 | Interferential Stimulator Model Inf 4150/a | Biomedical Life Systems, Inc. | 1992 | — |
| −3 | K952683 | Apex Medical Corp. Portable Interferential Stimulation Device | Wholesale Medical Imports, Inc. | 1997 | — |
| −2 | K032719 | GM3 Series IF Tens, Model GM3X2IF (Where X IS a Parameter of Different Housing) | Gemore Technology Co, Ltd. | 2003 | — |
| −1 | K042559 | Gem-Twin Tens/ Models GM3XY/Z | Gemore Technology Co, Ltd. | 2004 | — |
| 0 (this device) | K122948 | Gem-Stim Combo Stimulator | Gemore Technology Co, Ltd. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 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 |
|---|---|---|---|
| * | K042559 | Gem-Twin Tens/ Models GM3XY/ZSummary page 1…ator. Regulatory Class: 11 Product Code: GZJ, IPF, and LIH 3. Information of the 510(k) Cleared Device (Predicate Device)i: Gemore GEM-TWIN TENS/ Model GM38Y/Z (K042559). 4. Device Descriotion: The GEM-STIM Combo Stimulator; Model: GM304/GM504/GM384/GM394 is the combina- tion of transcutaneo… | 2004 |
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 20 years and passes through 3 companies; a new generation was cleared every 6.7 years on median.
- None of the 10 ancestors has a recall.
- 1 other device also cites its predicate K042559.
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. 2012, 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?
<1> For Transcutaneous electrical nerve stimulator.
This device is a prescription device and only for symptomatic relief of chronic intractable pain.
<2> For Power Muscle Stimulator.
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.
<3> For Interferential Stimulator.
The device is an interferential stimulator 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/K122948 · printed Nov 5, 2026
Cite this page
510(k) Report. “K122948: Gem-Stim Combo Stimulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K122948
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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