510(k) · Cleared
ClearedJKH Stimulator Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jkh USA, LLC · NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
Cleared on Mar 14, 2019 as substantially equivalent to K162517 (Jkh Health Co., Ltd., 2017) and 3 other predicates after a 211-day review. Its family tree reaches back 7 generations to 1988. 7 later devices descend from it.
- Decided
- Mar 14, 2019
- Review
- 211 days
- Class
- Class II
- Product code
- NUH
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K881114 (1988). 49 ancestors in all, the oldest K872976 (1987). 7 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK881114 Empi Model 989, TensEmpi · 1988
- 6 generations backK970203 Epix VTEmpi · 1997
- 5 generations backK061650 Select Tens, Model 4600SEmpi · 2007
- 4 generations backK090922 Empi Active Transcutaneous Nerve StimulatorEmpi · 2009
- 3 generations backK121184 SensusNeurometrix, Inc. · 2012
- 2 generations backK130919 SensusNeurometrix, Inc. · 2013
- 1 generation backK140333 AscendNeurometrix, Inc. · 2014
- This deviceK182203 JKH Stimulator PlusJkh USA, LLC · 2019
- Descendant · cites it directly · 4 of its ownK191151 JKH Stimulator PlusJkh USA, LLC · 2019
- Descendant · 2 generations on · 1 of its ownK231569 ManaFlexx 2 (model: MF002-RX, MF002-OTC)Manamed, Inc. · 2023
- Descendant · cites it directly · 1 of its ownK202159 actiTENSSublimed · 2020
- Descendant · cites it directly · 0 of its ownK252767 actiTENS miniSublimed · 2026
- Descendant · 3 generations on · 0 of its ownK243613 Patch-TEA (Model TRI-21)Transtimulation Research, Inc. · 2025
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K191151JKH Stimulator PlusJkh USA, LLC · 2019 · cites it directly4descendants
- K231569ManaFlexx 2 (model: MF002-RX, MF002-OTC)Manamed, Inc. · 2023 · 2 generations on1descendant
- K202159actiTENSSublimed · 2020 · cites it directly1descendant
- K252767actiTENS miniSublimed · 2026 · cites it directly0descendants
- K243613Patch-TEA (Model TRI-21)Transtimulation Research, Inc. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K881114 | Empi Model 989, Tens | Empi | 1988 | — |
| −6 | K970203 | Epix VT | Empi | 1997 | — |
| −5 | K061650 | Select Tens, Model 4600S | Empi | 2007 | — |
| −4 | K090922 | Empi Active Transcutaneous Nerve Stimulator | Empi | 2009 | — |
| −3 | K121184 | Sensus | Neurometrix, Inc. | 2012 | — |
| −2 | K130919 | Sensus | Neurometrix, Inc. | 2013 | — |
| −1 | K140333 | Ascend | Neurometrix, Inc. | 2014 | — |
| 0 (this device) | K182203 | JKH Stimulator Plus | Jkh USA, LLC | 2019 | — |
| +1 | K191151 | JKH Stimulator Plus | Jkh USA, LLC | 2019 | — |
| +2 | K231569 | ManaFlexx 2 (model: MF002-RX, MF002-OTC) | Manamed, Inc. | 2023 | — |
| +1 | K202159 | actiTENS | Sublimed | 2020 | — |
| +1 | K252767 | actiTENS mini | Sublimed | 2026 | — |
| +3 | K243613 | Patch-TEA (Model TRI-21) | Transtimulation Research, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1991 | 2 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2007 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 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? (4)
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 6…n Number: 21 CFR 882.5890 Device Class: II Use: Over-The-Counter (OTC) and Prescription 3. Predicate device Predicate Device: Electronic Pulse Stimulator 510(k) Number: K162517 Clearance Date: April 14, 2017 Submitter: JKH Health Co., Ltd. Predicate Device: Sys*Stim ME 208 510(k) Number: K031017 Clearanc… | 2017 |
| * | K031017 | Sys*Stim 208 and 208ASummary page 6…vice: Electronic Pulse Stimulator 510(k) Number: K162517 Clearance Date: April 14, 2017 Submitter: JKH Health Co., Ltd. Predicate Device: Sys*Stim ME 208 510(k) Number: K031017 Clearance Date: May 30, 2003 Submitter: Mettler Electronics Corp. Predicate Device: ASCEND 510(k) Number: K140333 Clearance Date… | 2003 |
| * | K140333 | AscendSummary page 6…Ltd. Predicate Device: Sys*Stim ME 208 510(k) Number: K031017 Clearance Date: May 30, 2003 Submitter: Mettler Electronics Corp. Predicate Device: ASCEND 510(k) Number: K140333 Clearance Date: July 3, 2014 Submitter: NeuroMetrix, Inc. Predicate Device: Strive 510(k) Number: K153704 Clearance Date: June 3… | 2014 |
| * | K153704 | StriveSummary page 6…ler Electronics Corp. Predicate Device: ASCEND 510(k) Number: K140333 Clearance Date: July 3, 2014 Submitter: NeuroMetrix, Inc. Predicate Device: Strive 510(k) Number: K153704 Clearance Date: June 3, 2016 Submitter: DJO, LLC 4. Description of Subject Device The subject device delivers electric pulses ge… | 2016 |
What descends from it? (7)
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 31 years and passes through 3 companies; a new generation was cleared every 3.2 years on median.
- 1 of the 49 ancestors has a recall of any class.
- Of its descendants, K191151 (Jkh USA, LLC, 2019) has gone furthest, with 4 descendants 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. 2019, 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): PL-029K12 and PL-029K13 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-029K12 and PL-029K13 are also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis. The device of PL-029K12 may be used during sleep. The…
Read the full statement (265 words)
TENS (Modes 1, 2, 4, 5, 6, 8):
PL-029K12 and PL-029K13 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-029K12 and PL-029K13 are also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
The device of PL-029K12 may be used during sleep. The device of PL-029K12 is labeled for use only with its own compatible electrodes.
PMS (also called EMS, Modes 1, 3, 7):
PL-029K12 and PL-029K13 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-029K12 and PL-029K13 are also intended to temporarily increase local blood circulation in the healthy muscles of lower extremities.
Heating:
The device of PL-029K13 is intended for temporary relief of minor aches and pains.
PL-029K12 and PL-029K13 are intended for the following use:
- Symptomatic relief and management of chronic, intractable pain
- Adjunctive treatment for post-surgical and post-trauma acute pain
- Relief of pain associated with arthritis
- Temporary relaxation of muscle spasm
- Prevention or retardation of disuse atrophy
- Muscle re-education
- Maintaining or increasing range of motion
- Increase of local blood flow in the treatment area
- Prevention of post-surgical venous thrombosis through immediate stimulation of calf muscles
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/K182203 · printed Nov 5, 2026
Cite this page
510(k) Report. “K182203: JKH Stimulator Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K182203
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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