510(k) · Cleared
ClearedStimPlus Patch, StimPlus Patch, StimPlus Patch
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 Jul 1, 2020 as substantially equivalent to K162517 (Jkh Health Co., Ltd., 2017) and 1 other predicate after a 119-day review. Its family tree reaches back 7 generations to 1994. 2 later devices descend from it.
- Decided
- Jul 1, 2020
- Review
- 119 days
- Class
- Class II
- Product code
- NUH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K940301 (1994). 28 ancestors in all, the oldest K880042 (1988). 2 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK940301 Compex 2Biodex Medical Systems, Inc. · 1994
- 6 generations backK011880 Compex SportCompex S.A. · 2002
- 5 generations backK060846 Therapeutic Massage CompanionEndurance Therapeutics · 2007
- 4 generations backK102598 HI-Dow-XPHi-Dow International, Inc. · 2011
- 3 generations backK122744 Prospera Otc Tens Electronic Pulse MassagerProspera Corporation · 2013
- 2 generations backK131921 Electronic Pulse StimulatorShenzhen Jingkehui Electronic Co.., Ltd. · 2013
- 1 generation backK141260 Electronic Pulse StimulatorShenzhen Jingkehui Electronic Co.., Ltd. · 2014
- This deviceK200561 StimPlus Patch, StimPlus Patch, StimPlus PatchJkh Health Co., Ltd. · 2020
- Descendant · cites it directly · 1 of its ownK211942 Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623…Shenzhen Osto Technology Company Limited · 2021
- Descendant · 2 generations on · 0 of its ownK223428 Electronic Stimulator (Models: uLumb-9530A, uLumb-9531A…Shenzhen Leqing Medical Instrument Co., Ltd. · 2023
Most influential descendants
Showing 2 of 2 · See all- K211942Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B)Shenzhen Osto Technology Company Limited · 2021 · cites it directly1descendant
- K223428Electronic Stimulator (Models: uLumb-9530A, uLumb-9531A, uLumb-9532A, uLumb-9533A…Shenzhen Leqing Medical Instrument Co., Ltd. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K940301 | Compex 2 | Biodex Medical Systems, Inc. | 1994 | — |
| −6 | K011880 | Compex Sport | Compex S.A. | 2002 | — |
| −5 | K060846 | Therapeutic Massage Companion | Endurance Therapeutics | 2007 | — |
| −4 | K102598 | HI-Dow-XP | Hi-Dow International, Inc. | 2011 | — |
| −3 | K122744 | Prospera Otc Tens Electronic Pulse Massager | Prospera Corporation | 2013 | — |
| −2 | K131921 | Electronic Pulse Stimulator | Shenzhen Jingkehui Electronic Co.., Ltd. | 2013 | — |
| −1 | K141260 | Electronic Pulse Stimulator | Shenzhen Jingkehui Electronic Co.., Ltd. | 2014 | — |
| 0 (this device) | K200561 | StimPlus Patch, StimPlus Patch, StimPlus Patch | Jkh Health Co., Ltd. | 2020 | — |
| +1 | K211942 | Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B) | Shenzhen Osto Technology Company Limited | 2021 | — |
| +2 | K223428 | Electronic Stimulator (Models: uLumb-9530A, uLumb-9531A, uLumb-9532A… | Shenzhen Leqing Medical Instrument Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1991 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2007 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K162517 | Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13Summary 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: K162517 Clearance Date: April 14, 2017 Submitter: JKH Health Co., Ltd. Predicate Device: Electronic Pulse Stimulator 510(k) Number: K141… | 2017 |
| * | K141260 | Electronic Pulse StimulatorSummary page 4…onic Pulse Stimulator 510(k) Number: K162517 Clearance Date: April 14, 2017 Submitter: JKH Health Co., Ltd. Predicate Device: Electronic Pulse Stimulator 510(k) Number: K141260 Clearance Date: September 17, 2014 Submitter: Shenzhen Jingkehui Electronic Co., Ltd. 4. Description of Subject Device The subje… | 2014 |
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 |
|---|---|---|---|
| K211942 | Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B) | 2021 | 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 26 years and passes through 7 companies; a new generation was cleared every 3.4 years on median.
- None of the 28 ancestors has a recall.
- Of its descendants, K211942 (Shenzhen Osto Technology Company Limited, 2021) has gone furthest, with 1 descendant of its own.
- 6 other devices also cite its predicate K162517.
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. 2020, 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: PL-029K29, PL-029K30, and PL-029Q are 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. PL-029K29, PL-029K30, and PL-029Q) are also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis. PMS: PL-029K29, PL-029K30, and PL-029Q) are used to stimulate…
Read the full statement (152 words)
TENS:
PL-029K29, PL-029K30, and PL-029Q are 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.
PL-029K29, PL-029K30, and PL-029Q) are also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
PMS:
PL-029K29, PL-029K30, and PL-029Q) are used 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.
PL-029K29, PL-029K30, and PL-029Q are also intended to temporarily increase local blood circulation in the healthy muscles of lower extremities.
Heating:
PL-029K30 and PL-029Q is intended for temporary relief of minor aches and pains.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K200561 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200561: StimPlus Patch, StimPlus Patch, StimPlus Patch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200561
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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