510(k) · Cleared
ClearedShian Jia Meei Two Channel Digital T.E.N.S.
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 Nov 4, 2005 as substantially equivalent to K990787 (Ito Co., Ltd., 1999) after an 86-day review. Its family tree reaches back 3 generations to 1991. 27 later devices descend from it.
- Decided
- Nov 4, 2005
- Review
- 86 days
- Class
- Class II
- Product code
- GZJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K912178 (1991). 7 ancestors in all, the oldest K880042 (1988). 27 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK912178 Bio Tens 601, 606 and 608 (3000)Skylark Device Co., Ltd. · 1991
- 2 generations backK972244 NT2000Bio-Medical Research, Ltd. · 1998
- 1 generation backK990787 TRIO 300Ito Co., Ltd. · 1999
- This deviceK052182 Shian Jia Meei Two Channel Digital T.E.N.S.Shian Jia Meei Enterprise Co., Ltd. · 2005
- Descendant · cites it directly · 26 of its ownK070299 Ezfit Digital Heating Tens (Model NO.: HR-661/UC-101)Ezfit Technology, Inc. · 2007
- Descendant · 2 generations on · 25 of its ownK162517 Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13Jkh Health Co., Ltd. · 2017
- Descendant · 3 generations on · 7 of its ownK182203 JKH Stimulator PlusJkh USA, LLC · 2019
- Descendant · 3 generations on · 4 of its ownK203574 HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical…Hivox Biotek, Inc. · 2021
- Descendant · 4 generations on · 4 of its ownK191151 JKH Stimulator PlusJkh USA, LLC · 2019
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K070299Ezfit Digital Heating Tens (Model NO.: HR-661/UC-101)Ezfit Technology, Inc. · 2007 · cites it directly26descendants
- K162517Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13Jkh Health Co., Ltd. · 2017 · 2 generations on25descendants
- K182203JKH Stimulator PlusJkh USA, LLC · 2019 · 3 generations on7descendants
- K203574HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2Hivox Biotek, Inc. · 2021 · 3 generations on4descendants
- K191151JKH Stimulator PlusJkh USA, LLC · 2019 · 4 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K912178 | Bio Tens 601, 606 and 608 (3000) | Skylark Device Co., Ltd. | 1991 | — |
| −2 | K972244 | NT2000 | Bio-Medical Research, Ltd. | 1998 | — |
| −1 | K990787 | TRIO 300 | Ito Co., Ltd. | 1999 | — |
| 0 (this device) | K052182 | Shian Jia Meei Two Channel Digital T.E.N.S. | Shian Jia Meei Enterprise Co., Ltd. | 2005 | — |
| +1 | K070299 | Ezfit Digital Heating Tens (Model NO.: HR-661/UC-101) | Ezfit Technology, Inc. | 2007 | — |
| +2 | K162517 | Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13 | Jkh Health Co., Ltd. | 2017 | — |
| +3 | K182203 | JKH Stimulator Plus | Jkh USA, LLC | 2019 | — |
| +3 | K203574 | HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2 | Hivox Biotek, Inc. | 2021 | — |
| +4 | K191151 | JKH Stimulator Plus | Jkh USA, LLC | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 4 | 0 |
| 2020 | 4 | 0 |
| 2021 | 5 | 0 |
| 2022 | 3 | 0 |
| 2023 | 6 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K990787 | TRIO 300Summary page 1…ulator 3. Classification: Class II 4. Predicate Device: The predicate device is the TRIO 300 Multi-mode Electrical Stimulator (k990787) marketed by ITO CO., LTD. 5. Device Description: SHIAN JlA MEEI TWO Channel Digital T.E.N.S.( Transcuntaneus… | 1999 |
What descends from it? (27)
See all 271 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070299 | Ezfit Digital Heating Tens (Model NO.: HR-661/UC-101) | 2007 | 26 |
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 14 years and passes through 4 companies; a new generation was cleared every 6.0 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K070299 (Ezfit Technology, Inc., 2007) has gone furthest, with 26 descendants of its own.
- 2 other devices also cite its predicate K990787.
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 TWO Channel Digital T.E.N.S. is intended for symptomatic relief and management of chronic intractable pain.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052182 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052182: Shian Jia Meei Two Channel Digital T.E.N.S..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052182
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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