510(k) · Cleared
ClearedTranscutaneous Electrical Nerve Stimulator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Top-Rank Health Care Co., Ltd. · NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
Cleared on Dec 15, 2021 as substantially equivalent to K152374 (Fuji Dynamics, Ltd., 2016) after a 321-day review. Its family tree reaches back 2 generations to 2011. 2 later devices descend from it.
- Decided
- Dec 15, 2021
- Review
- 321 days
- Class
- Class II
- Product code
- NUH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K102051 (2011). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK102051 Pain BuddyBiomedical Life Systems, Inc. · 2011
- 1 generation backK152374 LL Tens 160A, LL Tens 160BFuji Dynamics, Ltd. · 2016
- This deviceK210223 Transcutaneous Electrical Nerve StimulatorTop-Rank Health Care Co., Ltd. · 2021
- Descendant · cites it directly · 1 of its ownK231425 Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1)Wuxi Jiajian Medical Instrument Co., Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK252688 Transcutaneous Electrical Nerve Stimulator (RJTENS-2)Bozhou Rongjian Medical Appliance Co., Ltd. · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K102051 | Pain Buddy | Biomedical Life Systems, Inc. | 2011 | — |
| −1 | K152374 | LL Tens 160A, LL Tens 160B | Fuji Dynamics, Ltd. | 2016 | — |
| 0 (this device) | K210223 | Transcutaneous Electrical Nerve Stimulator | Top-Rank Health Care Co., Ltd. | 2021 | — |
| +1 | K231425 | Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1) | Wuxi Jiajian Medical Instrument Co., Ltd. | 2024 | — |
| +2 | K252688 | Transcutaneous Electrical Nerve Stimulator (RJTENS-2) | Bozhou Rongjian Medical Appliance Co., Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 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 NUH? 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 NUH device
- #1 K190783 Health Expert Electronic Stimulator (model…score 15.8 · 7 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 |
|---|---|---|---|
| * | K152374 | LL Tens 160A, LL Tens 160BSummary page 6… Post surgical pain adjunctive treatment 4. Legally Marketed Predicate Device Product name:Transcutaneous Electrical Nerve Stimulator (T.E.N.S) 510(k) Number: K152374 Product Code: NUH Manufacture: Fuji Dynamics Ltd 5.Description of the device The proposed device is transcutaneous elec… | 2016 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K231425 | Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1) | 2024 | 1 |
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 10 years and passes through 3 companies; a new generation was cleared every 5.9 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K231425 (Wuxi Jiajian Medical Instrument Co., Ltd., 2024) has gone furthest, with 1 descendant of its own.
How does its category compare?
All NUH devicesNUH Stimulator, Nerve, Transcutaneous, Over-The-Counter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · NUH
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NUH
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NUH
No recall names NUH since 2007.
Adverse event reports per year · NUH
7in 2025
MAUDE reports naming product code NUH, 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 | 4 | 161 | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 3 | 148 | 0 | 0 |
| 2011 | 6 | 231 | 0 | 0 |
| 2012 | 6 | 170 | 0 | 0 |
| 2013 | 10 | 189 | 0 | 1 |
| 2014 | 16 | 212 | 0 | 9 |
| 2015 | 14 | 198 | 0 | 11 |
| 2016 | 13 | 145 | 0 | 13 |
| 2017 | 17 | 155 | 0 | 21 |
| 2018 | 16 | 121 | 0 | 18 |
| 2019 | 19 | 213 | 0 | 5 |
| 2020 | 14 | 147 | 0 | 8 |
| 2021 | 14 | 198 | 0 | 7 |
| 2022 | 20 | 103 | 0 | 2 |
| 2023 | 15 | 127 | 0 | 4 |
| 2024 | 20 | 90 | 0 | 7 |
| 2025 | 15 | 119 | 0 | 7 |
| 2026 | 5 | 137 | 0 | — |
What is it indicated for?
The TOPTENS-01 can be used for the Symptomatic relief of chronic intractable pain, Post traumatic pain adjunctive treatment, Post-surgical pain adjunctive treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210223 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210223: Transcutaneous Electrical Nerve Stimulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210223
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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