510(k) · Cleared
ClearedShian Jia Meei Digatal PWN Tens, Model YW-6000/UC-332/UC-330/ST-331
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shian Jia Meei Enterprise Co., Ltd. · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Cleared on Oct 1, 2004 as substantially equivalent to K021794 (Tatung Co., 2003) after a 235-day review. Its family tree reaches back 2 generations to 2001.
- Decided
- Oct 1, 2004
- Review
- 235 days
- Class
- Class II
- Product code
- GZJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K003487 (2001). No later device cites it as a predicate yet.
- Root · 2 generations backK003487 Stimate N601 TensEveryway Medical Instruments Co.,Ltd · 2001
- 1 generation backK021794 Tatung TMD-26AX Series Tens, Models NO. TMD-26AB Tatung Tens (Blue…Tatung Co. · 2003
- This deviceK040311 Shian Jia Meei Digatal PWN Tens, Model YW-6000/UC-332/UC-330/ST-331Shian Jia Meei Enterprise Co., Ltd. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K003487 | Stimate N601 Tens | Everyway Medical Instruments Co.,Ltd | 2001 | — |
| −1 | K021794 | Tatung TMD-26AX Series Tens, Models NO. TMD-26AB Tatung Tens (Blue Housing)… | Tatung Co. | 2003 | — |
| 0 (this device) | K040311 | Shian Jia Meei Digatal PWN Tens, Model YW-6000/UC-332/UC-330/ST-331 | Shian Jia Meei Enterprise Co., Ltd. | 2004 | — |
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 |
|---|---|---|---|
| * | K021794 | Tatung TMD-26AX Series Tens, Models NO. TMD-26AB Tatung Tens (Blue Housing) TMD-26AY…Summary page 1…Classification name: Transcutaneous Electrical Nerve Stimulator 3. Classification: Class II 4. Predicate Device: TATUNG TMD-26AX Series TENS(K021794) marketed by Tatung Co.. 5. Device Description: The SHIAN JIA MEEI DIGITAL PWM TENS (Transc… | 2003 |
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 3 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
- None of the 2 ancestors has a recall.
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 SHIAN JIA MEEI DIGITAL PWM 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/K040311 · printed Nov 4, 2026
Cite this page
510(k) Report. “K040311: Shian Jia Meei Digatal PWN Tens, Model YW-6000/UC-332/UC-330/ST-331.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040311
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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