510(k) · Cleared
ClearedElectronic Pulse Stimulator
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 May 5, 2016 after a 149-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 27 later devices descend from it.
- Decided
- May 5, 2016
- Review
- 149 days
- Class
- Class II
- Product code
- NUH
- Recalls
- None
- Predicates
- 0
27 later devices descend from it, 2 citing it directly.
- This deviceK153520 Electronic Pulse StimulatorJkh Health Co., Ltd. · 2016
- Descendant · cites it directly · 25 of its ownK162517 Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13Jkh Health Co., Ltd. · 2017
- Descendant · 2 generations on · 7 of its ownK182203 JKH Stimulator PlusJkh USA, LLC · 2019
- Descendant · 2 generations on · 4 of its ownK203574 HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical…Hivox Biotek, Inc. · 2021
- Descendant · 3 generations on · 4 of its ownK191151 JKH Stimulator PlusJkh USA, LLC · 2019
- Descendant · 2 generations on · 3 of its ownK211403 HIVOX OTC Electrical Stimulator, FT610-BHivox Biotek, Inc. · 2021
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K162517Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13Jkh Health Co., Ltd. · 2017 · cites it directly25descendants
- K182203JKH Stimulator PlusJkh USA, LLC · 2019 · 2 generations on7descendants
- K203574HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2Hivox Biotek, Inc. · 2021 · 2 generations on4descendants
- K191151JKH Stimulator PlusJkh USA, LLC · 2019 · 3 generations on4descendants
- K211403HIVOX OTC Electrical Stimulator, FT610-BHivox Biotek, Inc. · 2021 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K153520 | Electronic Pulse Stimulator | Jkh Health Co., Ltd. | 2016 | — |
| +1 | K162517 | Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13 | Jkh Health Co., Ltd. | 2017 | — |
| +2 | K182203 | JKH Stimulator Plus | Jkh USA, LLC | 2019 | — |
| +2 | K203574 | HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2 | Hivox Biotek, Inc. | 2021 | — |
| +3 | K191151 | JKH Stimulator Plus | Jkh USA, LLC | 2019 | — |
| +2 | K211403 | HIVOX OTC Electrical Stimulator, FT610-B | Hivox Biotek, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 4 | 0 |
| 2020 | 5 | 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 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (27)
See all 272 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?
- Of its descendants, K162517 (Jkh Health Co., Ltd., 2017) has gone furthest, with 25 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. 2016, 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) 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 (Modes 1 and 3) To stimulate healthy muscles in order to improve and facilitate muscle performance.…
Read the full statement (133 words)
TENS (Modes 1, 2, 4, 5, 6)
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 (Modes 1 and 3)
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.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K153520 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153520: 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/K153520
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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