510(k) · Cleared
ClearedAcuplus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
S.H.P. Intl. Pty., Ltd. · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Cleared on Jan 22, 1996 after a 126-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 14 later devices descend from it.
- Decided
- Jan 22, 1996
- Review
- 126 days
- Class
- Class II
- Product code
- GZJ
- Recalls
- None
- Predicates
- 0
14 later devices descend from it, 1 citing it directly.
- This deviceK954334 AcuplusS.H.P. Intl. Pty., Ltd. · 1996
- Descendant · cites it directly · 13 of its ownK014273 AcustimS.H.P. Intl. Pty., Ltd. · 2002
- Descendant · 2 generations on · 9 of its ownK051197 Aculife, Model SMW-01Inno-Health Technology, Inc. · 2006
- Descendant · 3 generations on · 7 of its ownK081943 Model ES-130Ito Co., Ltd. · 2008
- Descendant · 4 generations on · 3 of its ownK130768 Jiajian CMN StimulatorWuxi Jiajian Medical Instrument Co., Ltd. · 2013
- Descendant · 5 generations on · 2 of its ownK202861 Needle StimulatorWuxi Jiajian Medical Instrument Co., Ltd. · 2021
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K014273AcustimS.H.P. Intl. Pty., Ltd. · 2002 · cites it directly13descendants
- K051197Aculife, Model SMW-01Inno-Health Technology, Inc. · 2006 · 2 generations on9descendants
- K081943Model ES-130Ito Co., Ltd. · 2008 · 3 generations on7descendants
- K130768Jiajian CMN StimulatorWuxi Jiajian Medical Instrument Co., Ltd. · 2013 · 4 generations on3descendants
- K202861Needle StimulatorWuxi Jiajian Medical Instrument Co., Ltd. · 2021 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K954334 | Acuplus | S.H.P. Intl. Pty., Ltd. | 1996 | — |
| +1 | K014273 | Acustim | S.H.P. Intl. Pty., Ltd. | 2002 | — |
| +2 | K051197 | Aculife, Model SMW-01 | Inno-Health Technology, Inc. | 2006 | — |
| +3 | K081943 | Model ES-130 | Ito Co., Ltd. | 2008 | — |
| +4 | K130768 | Jiajian CMN Stimulator | Wuxi Jiajian Medical Instrument Co., Ltd. | 2013 | — |
| +5 | K202861 | Needle Stimulator | Wuxi Jiajian Medical Instrument Co., Ltd. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2025 | 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (14)
See all 141 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K014273 | Acustim | 2002 | 13 |
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, K014273 (S.H.P. Intl. Pty., Ltd., 2002) has gone furthest, with 13 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/K954334 · printed Nov 6, 2026
Cite this page
510(k) Report. “K954334: Acuplus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K954334
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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