510(k) · Cleared
ClearedFdtens 2010
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fuji Dynamics Limited · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Cleared on Jul 6, 2000 after a 202-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 20 later devices descend from it.
- Decided
- Jul 6, 2000
- Review
- 202 days
- Class
- Class II
- Product code
- GZJ
- Recalls
- None
- Predicates
- 0
20 later devices descend from it, 4 citing it directly.
- This deviceK994266 Fdtens 2010Fuji Dynamics Limited · 2000
- Descendant · cites it directly · 13 of its ownK040253 Easy Med TN-28 CEasy Med Instrument Co., Ltd. · 2004
- Descendant · 2 generations on · 6 of its ownK140168 Easystim TN28_OtcEasymed Instruments Co., Ltd. · 2014
- Descendant · cites it directly · 5 of its ownK020846 Ultima Tens XL-A1Tenscare, Ltd. · 2002
- Descendant · 2 generations on · 4 of its ownK023997 Tenscare Ultima NMS/EmsTenscare, Ltd. · 2003
- Descendant · 2 generations on · 3 of its ownK050921 Easystim NMS-28Easy Med Instrument Co., Ltd. · 2005
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K040253Easy Med TN-28 CEasy Med Instrument Co., Ltd. · 2004 · cites it directly13descendants
- K140168Easystim TN28_OtcEasymed Instruments Co., Ltd. · 2014 · 2 generations on6descendants
- K020846Ultima Tens XL-A1Tenscare, Ltd. · 2002 · cites it directly5descendants
- K023997Tenscare Ultima NMS/EmsTenscare, Ltd. · 2003 · 2 generations on4descendants
- K050921Easystim NMS-28Easy Med Instrument Co., Ltd. · 2005 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K994266 | Fdtens 2010 | Fuji Dynamics Limited | 2000 | — |
| +1 | K040253 | Easy Med TN-28 C | Easy Med Instrument Co., Ltd. | 2004 | — |
| +2 | K140168 | Easystim TN28_Otc | Easymed Instruments Co., Ltd. | 2014 | — |
| +1 | K020846 | Ultima Tens XL-A1 | Tenscare, Ltd. | 2002 | — |
| +2 | K023997 | Tenscare Ultima NMS/Ems | Tenscare, Ltd. | 2003 | — |
| +2 | K050921 | Easystim NMS-28 | Easy Med Instrument Co., Ltd. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 2 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (20)
See all 204 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, K040253 (Easy Med Instrument Co., Ltd., 2004) 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 | — |
What is it indicated for?
TENS stands for Transcutaneous Electrical Nerve Stimulation and is a non-invasive and drug-free pain management unit. The TENS system is designed for the treatment of pain - chronic,
acute or post-operative pain.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K994266 · printed Nov 4, 2026
Cite this page
510(k) Report. “K994266: Fdtens 2010.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K994266
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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