510(k) · Cleared
ClearedPGS123 and HVS-123
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Skylark Device Co., Ltd. · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Cleared on Jun 26, 1995 after a 181-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 13 later devices descend from it.
- Decided
- Jun 26, 1995
- Review
- 181 days
- Class
- Class II
- Product code
- GZJ
- Recalls
- None
- Predicates
- 0
13 later devices descend from it, 3 citing it directly.
- This deviceK946299 PGS123 and HVS-123Skylark Device Co., Ltd. · 1995
- Descendant · cites it directly · 7 of its ownK032994 GM3 Series HV Tens, Model GM3X3HV (Where X IS Parameter of Different…Gemore Technology Co, Ltd. · 2003
- Descendant · cites it directly · 3 of its ownK081835 Acticare IC and TseBioinduction Limited · 2009
- Descendant · 2 generations on · 2 of its ownK161091 STIMPOD NMS460 Nerve StimulatorXavant Technology (Pty), Ltd. · 2017
- Descendant · 2 generations on · 2 of its ownK071120 Aemed Stimpad Acu-Tens Transcutaneous Electrical Nerve Stimulator…Aemed, Inc. · 2008
- Descendant · 2 generations on · 2 of its ownK042559 Gem-Twin Tens/ Models GM3XY/ZGemore Technology Co, Ltd. · 2004
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K032994GM3 Series HV Tens, Model GM3X3HV (Where X IS Parameter of Different Housing)Gemore Technology Co, Ltd. · 2003 · cites it directly7descendants
- K081835Acticare IC and TseBioinduction Limited · 2009 · cites it directly3descendants
- K161091STIMPOD NMS460 Nerve StimulatorXavant Technology (Pty), Ltd. · 2017 · 2 generations on2descendants
- K071120Aemed Stimpad Acu-Tens Transcutaneous Electrical Nerve Stimulator, Model 021999Aemed, Inc. · 2008 · 2 generations on2descendants
- K042559Gem-Twin Tens/ Models GM3XY/ZGemore Technology Co, Ltd. · 2004 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K946299 | PGS123 and HVS-123 | Skylark Device Co., Ltd. | 1995 | — |
| +1 | K032994 | GM3 Series HV Tens, Model GM3X3HV (Where X IS Parameter of Different Housing) | Gemore Technology Co, Ltd. | 2003 | — |
| +1 | K081835 | Acticare IC and Tse | Bioinduction Limited | 2009 | — |
| +2 | K161091 | STIMPOD NMS460 Nerve Stimulator | Xavant Technology (Pty), Ltd. | 2017 | — |
| +2 | K071120 | Aemed Stimpad Acu-Tens Transcutaneous Electrical Nerve Stimulator, Model 021999 | Aemed, Inc. | 2008 | — |
| +2 | K042559 | Gem-Twin Tens/ Models GM3XY/Z | Gemore Technology Co, Ltd. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2022 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (13)
See all 133 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?
- Of its descendants, K032994 (Gemore Technology Co, Ltd., 2003) has gone furthest, with 7 descendants of its own.
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 | — |
https://510kreport.com/device/K946299 · printed Nov 5, 2026
Cite this page
510(k) Report. “K946299: PGS123 and HVS-123.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K946299
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026