510(k) · Cleared
ClearedElectronic Pulse Stimulator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Jingkehui Electronic Co.., Ltd. · NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
Cleared on Sep 17, 2014 as substantially equivalent to K131921 (Shenzhen Jingkehui Electronic Co.., Ltd., 2013) and 1 other predicate after a 125-day review. Its family tree reaches back 6 generations to 1994. 5 later devices descend from it.
- Decided
- Sep 17, 2014
- Review
- 125 days
- Class
- Class II
- Product code
- NUH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K940301 (1994). 12 ancestors in all. 5 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK940301 Compex 2Biodex Medical Systems, Inc. · 1994
- 5 generations backK011880 Compex SportCompex S.A. · 2002
- 4 generations backK060846 Therapeutic Massage CompanionEndurance Therapeutics · 2007
- 3 generations backK102598 HI-Dow-XPHi-Dow International, Inc. · 2011
- 2 generations backK122744 Prospera Otc Tens Electronic Pulse MassagerProspera Corporation · 2013
- 1 generation backK131921 Electronic Pulse StimulatorShenzhen Jingkehui Electronic Co.., Ltd. · 2013
- This deviceK141260 Electronic Pulse StimulatorShenzhen Jingkehui Electronic Co.., Ltd. · 2014
- Descendant · cites it directly · 2 of its ownK200561 StimPlus Patch, StimPlus Patch, StimPlus PatchJkh Health Co., Ltd. · 2020
- Descendant · 2 generations on · 1 of its ownK211942 Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623…Shenzhen Osto Technology Company Limited · 2021
- Descendant · 3 generations on · 0 of its ownK223428 Electronic Stimulator (Models: uLumb-9530A, uLumb-9531A…Shenzhen Leqing Medical Instrument Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK182671 Medi-Direct TENS PenJkh USA, LLC · 2019
- Descendant · cites it directly · 0 of its ownK170145 Digital TENS UnitShenzhen Eapply Technology Co., Ltd. · 2017
Most influential descendants
Showing 5 of 5 · See all- K200561StimPlus Patch, StimPlus Patch, StimPlus PatchJkh Health Co., Ltd. · 2020 · cites it directly2descendants
- K211942Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B)Shenzhen Osto Technology Company Limited · 2021 · 2 generations on1descendant
- K223428Electronic Stimulator (Models: uLumb-9530A, uLumb-9531A, uLumb-9532A, uLumb-9533A…Shenzhen Leqing Medical Instrument Co., Ltd. · 2023 · 3 generations on0descendants
- K182671Medi-Direct TENS PenJkh USA, LLC · 2019 · cites it directly0descendants
- K170145Digital TENS UnitShenzhen Eapply Technology Co., Ltd. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K940301 | Compex 2 | Biodex Medical Systems, Inc. | 1994 | — |
| −5 | K011880 | Compex Sport | Compex S.A. | 2002 | — |
| −4 | K060846 | Therapeutic Massage Companion | Endurance Therapeutics | 2007 | — |
| −3 | K102598 | HI-Dow-XP | Hi-Dow International, Inc. | 2011 | — |
| −2 | K122744 | Prospera Otc Tens Electronic Pulse Massager | Prospera Corporation | 2013 | — |
| −1 | K131921 | Electronic Pulse Stimulator | Shenzhen Jingkehui Electronic Co.., Ltd. | 2013 | — |
| 0 (this device) | K141260 | Electronic Pulse Stimulator | Shenzhen Jingkehui Electronic Co.., Ltd. | 2014 | — |
| +1 | K200561 | StimPlus Patch, StimPlus Patch, StimPlus Patch | Jkh Health Co., Ltd. | 2020 | — |
| +2 | K211942 | Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B) | Shenzhen Osto Technology Company Limited | 2021 | — |
| +3 | K223428 | Electronic Stimulator (Models: uLumb-9530A, uLumb-9531A, uLumb-9532A… | Shenzhen Leqing Medical Instrument Co., Ltd. | 2023 | — |
| +1 | K182671 | Medi-Direct TENS Pen | Jkh USA, LLC | 2019 | — |
| +1 | K170145 | Digital TENS Unit | Shenzhen Eapply Technology Co., Ltd. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 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? (2)
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 |
|---|---|---|---|
| * | K131921 | Electronic Pulse StimulatorSummary page 4…uct Code: NUH Regulation Number: 21 CFR 882.5890 Device Class: II Use: Over-The-Counter 3. Predicate device Predicate Device: Electronic Pulse Stimulator 510(k) Number: K131921 Use: Over-The-Counter Submitter: Shenzhen Jingkehui Electronic Co., Ltd. Predicate Device: IQ Technologies 510(k) Number: K13129… | 2013 |
| * | K131290 | IQ Technologies Cleared while this submission was under review Summary page 4…tronic Pulse Stimulator 510(k) Number: K131921 Use: Over-The-Counter Submitter: Shenzhen Jingkehui Electronic Co., Ltd. Predicate Device: IQ Technologies 510(k) Number: K131290 Use: Over-The-Counter Submitter: IQ Technologies Inc. 4. Description of Subject Device The subject device is a Transcutaneous El… | 2014 |
What descends from it? (5)
3 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?
- The line of descent spans 20 years and passes through 6 companies; a new generation was cleared every 3.4 years on median.
- None of the 12 ancestors has a recall.
- Of its descendants, K200561 (Jkh Health Co., Ltd., 2020) has gone furthest, with 2 descendants 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. 2014, 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?
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, and leg, due to strain from exercise or normal household and work activities.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141260 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141260: Electronic Pulse Stimulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141260
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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