510(k) · Cleared
ClearedTatung TMD-26AX Series Tens, Models NO. TMD-26AB Tatung Tens (Blue Housing) TMD-26AY Tatung Tens (Yellow Housing)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tatung Co. · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Cleared on Jan 13, 2003 as substantially equivalent to K003487 (Everyway Medical Instruments Co.,Ltd, 2001) after a 227-day review. Its family tree reaches back 1 generation to 2001. 1 later device descends from it.
- Decided
- Jan 13, 2003
- Review
- 227 days
- Class
- Class II
- Product code
- GZJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K003487 (2001). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK003487 Stimate N601 TensEveryway Medical Instruments Co.,Ltd · 2001
- This deviceK021794 Tatung TMD-26AX Series Tens, Models NO. TMD-26AB Tatung Tens (Blue…Tatung Co. · 2003
- Descendant · cites it directly · 0 of its ownK040311 Shian Jia Meei Digatal PWN Tens, Model YW-6000/UC-332/UC-330/ST-331Shian Jia Meei Enterprise Co., Ltd. · 2004
Most influential descendants
Showing 1 of 1 · See all- K040311Shian Jia Meei Digatal PWN Tens, Model YW-6000/UC-332/UC-330/ST-331Shian Jia Meei Enterprise Co., Ltd. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003487 | Stimate N601 Tens | Everyway Medical Instruments Co.,Ltd | 2001 | — |
| 0 (this device) | K021794 | Tatung TMD-26AX Series Tens, Models NO. TMD-26AB Tatung Tens (Blue Housing)… | Tatung Co. | 2003 | — |
| +1 | K040311 | Shian Jia Meei Digatal PWN Tens, Model YW-6000/UC-332/UC-330/ST-331 | Shian Jia Meei Enterprise Co., Ltd. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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? (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 |
|---|---|---|---|
| * | K003487 | Stimate N601 TensSummary page 1…TENS unit Classification name: Transcutaneous Electrical Nerve Stimulator 3. Classification: Class II 4. Predicate Device: STIMATE TENS (K003487) marketed by EVERYWAY MEDICAL INSTRUMENTS CO., LTD. 5. Device Description: TATUNG TMD-26AX SE… | 2001 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040311 | Shian Jia Meei Digatal PWN Tens, Model YW-6000/UC-332/UC-330/ST-331 | 2004 | 0 |
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?
- Its one ancestor has no recall.
- Of its descendants, K040311 (Shian Jia Meei Enterprise Co., Ltd., 2004) has gone furthest, with 0 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?
The TATUNG TMD-26AX SERIES TENS is intended for symptomatic
relief and management of chronic intractable pain.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021794 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021794: Tatung TMD-26AX Series Tens, Models NO. TMD-26AB Tatung Tens (Blue Housing) TMD-26AY Tatung Tens (Yellow Housing).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021794
Report an extraction error
Are you the manufacturer?
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