510(k) · Cleared
ClearedElectronic Pulse Stimulator Model: PL-029K12 and PL-029K13
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jkh Health Co., Ltd. · NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
Cleared on Apr 14, 2017 as substantially equivalent to K153520 (Jkh Health Co., Ltd., 2016) and 1 other predicate after a 217-day review. Its family tree reaches back 5 generations to 1991. 25 later devices descend from it.
- Decided
- Apr 14, 2017
- Review
- 217 days
- Class
- Class II
- Product code
- NUH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K912178 (1991). 14 ancestors in all, the oldest K880042 (1988). 25 later devices descend from it, 7 citing it directly.
- Root · 5 generations backK912178 Bio Tens 601, 606 and 608 (3000)Skylark Device Co., Ltd. · 1991
- 4 generations backK972244 NT2000Bio-Medical Research, Ltd. · 1998
- 3 generations backK990787 TRIO 300Ito Co., Ltd. · 1999
- 2 generations backK023231 Elfcare Device, Models 314A Through 314GMediseb, Ltd. · 2003
- 1 generation backK070299 Ezfit Digital Heating Tens (Model NO.: HR-661/UC-101)Ezfit Technology, Inc. · 2007
- This deviceK162517 Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13Jkh Health Co., Ltd. · 2017
- Descendant · cites it directly · 7 of its ownK182203 JKH Stimulator PlusJkh USA, LLC · 2019
- Descendant · cites it directly · 4 of its ownK203574 HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical…Hivox Biotek, Inc. · 2021
- Descendant · 2 generations on · 4 of its ownK191151 JKH Stimulator PlusJkh USA, LLC · 2019
- Descendant · cites it directly · 3 of its ownK211403 HIVOX OTC Electrical Stimulator, FT610-BHivox Biotek, Inc. · 2021
- Descendant · cites it directly · 2 of its ownK200561 StimPlus Patch, StimPlus Patch, StimPlus PatchJkh Health Co., Ltd. · 2020
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K182203JKH Stimulator PlusJkh USA, LLC · 2019 · cites it directly7descendants
- K203574HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2Hivox Biotek, Inc. · 2021 · cites it directly4descendants
- K191151JKH Stimulator PlusJkh USA, LLC · 2019 · 2 generations on4descendants
- K211403HIVOX OTC Electrical Stimulator, FT610-BHivox Biotek, Inc. · 2021 · cites it directly3descendants
- K200561StimPlus Patch, StimPlus Patch, StimPlus PatchJkh Health Co., Ltd. · 2020 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K912178 | Bio Tens 601, 606 and 608 (3000) | Skylark Device Co., Ltd. | 1991 | — |
| −4 | K972244 | NT2000 | Bio-Medical Research, Ltd. | 1998 | — |
| −3 | K990787 | TRIO 300 | Ito Co., Ltd. | 1999 | — |
| −2 | K023231 | Elfcare Device, Models 314A Through 314G | Mediseb, Ltd. | 2003 | — |
| −1 | K070299 | Ezfit Digital Heating Tens (Model NO.: HR-661/UC-101) | Ezfit Technology, Inc. | 2007 | — |
| 0 (this device) | K162517 | Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13 | Jkh Health Co., Ltd. | 2017 | — |
| +1 | K182203 | JKH Stimulator Plus | Jkh USA, LLC | 2019 | — |
| +1 | K203574 | HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2 | Hivox Biotek, Inc. | 2021 | — |
| +2 | K191151 | JKH Stimulator Plus | Jkh USA, LLC | 2019 | — |
| +1 | K211403 | HIVOX OTC Electrical Stimulator, FT610-B | Hivox Biotek, Inc. | 2021 | — |
| +1 | K200561 | StimPlus Patch, StimPlus Patch, StimPlus Patch | Jkh Health Co., Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2005 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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 |
|---|---|---|---|
| * | K153520 | Electronic Pulse StimulatorSummary page 4…YN, IRT Regulation Number: 21 CFR 882.5890 Device Class: II Use: Over-The-Counter (OTC) 3. Predicate device Predicate Device: Electronic Pulse Stimulator 510(k) Number: K153520 Clearance Date: May 05, 2016 Submitter: JKH Health Co., Ltd. (Previous name: Shenzhen Jingkehui Electronic Co., Ltd.) Predicate… | 2016 |
| * | K070299 | Ezfit Digital Heating Tens (Model NO.: HR-661/UC-101)Summary page 4…JKH Health Co., Ltd. (Previous name: Shenzhen Jingkehui Electronic Co., Ltd.) Predicate Device: ezFit Digital Heating TENS Clearance Date: July 16, 2007 510(k) Number: K070299 Submitter: ezFit Technology, Inc. 4. Description of Subject Device Electronic Pulse Stimulator delivers electric pulses generate… | 2007 |
What descends from it? (25)
See all 257 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182203 | JKH Stimulator Plus | 2019 | 7 |
| K203574 | HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2 | 2021 | 4 |
| K211403 | HIVOX OTC Electrical Stimulator, FT610-B | 2021 | 3 |
| K200561 | StimPlus Patch, StimPlus Patch, StimPlus Patch | 2020 | 2 |
| K193275 | Nerve and Muscle Stimulator | 2020 | 2 |
| K192733 | RelieforMe TENS/EMS Device Model UPK-GE01 | 2019 | 1 |
| K182671 | Medi-Direct TENS Pen | 2019 | 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?
- The line of descent spans 26 years and passes through 6 companies; a new generation was cleared every 4.3 years on median.
- None of the 14 ancestors has a recall.
- Of its descendants, K182203 (Jkh USA, LLC, 2019) has gone furthest, with 7 descendants of its own.
- 1 other device also cites its predicate K153520.
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. 2017, 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?
TENS (Modes 1, 2, 4, 5, 6, 8) 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. It is also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis. PMS (also called EMS, Modes 1, 3, 7) To stimulate healthy muscles in order to improve and facilitate…
Read the full statement (146 words)
TENS (Modes 1, 2, 4, 5, 6, 8)
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.
It is also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
PMS (also called EMS, Modes 1, 3, 7)
To stimulate healthy muscles in order to improve and facilitate muscle performance. To be used for the improvement of muscle tone and firmness, and for strengthening muscles in the arms, abdomen, legs, and buttocks. Not intended for use in any therapy or for the treatment of any medical conditions or diseases.
It is also intended to temporarily increase local blood circulation in the healthy muscles of lower extremities.
Heating Mode
Temporary relief of minor aches and pains.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162517 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162517: Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162517
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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