510(k) · Cleared
ClearedMedi-Direct TENS Pen
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 Sep 21, 2019 as substantially equivalent to K162517 (Jkh Health Co., Ltd., 2017) and 2 other predicates after a 360-day review. Its family tree reaches back 7 generations to 1994.
- Decided
- Sep 21, 2019
- Review
- 360 days
- Class
- Class II
- Product code
- NUH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K940301 (1994). 35 ancestors in all, the oldest K880042 (1988). No later device cites it as a predicate yet.
- 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 deviceK182671 Medi-Direct TENS PenJkh USA, LLC · 2019
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) | K182671 | Medi-Direct TENS Pen | Jkh USA, LLC | 2019 | — |
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 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 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? (3)
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…de: NUH 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, 2014 Submitter: Shenzhen Jingkehui Electronic Co., Ltd. Predicate Device: Dolphin Neurostim OTC 510(k… | 2014 |
| * | K133789 | Dolphin Neurostim OtcSummary page 4…mulator 510(k) Number: K141260 Clearance Date: September, 2014 Submitter: Shenzhen Jingkehui Electronic Co., Ltd. Predicate Device: Dolphin Neurostim OTC 510(k) Number: K133789 Clearance Date: March 4, 2015 Submitter: Acumed Medical, Ltd. 4. Description of Subject Device The subject device is a hand-held… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
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 25 years and passes through 7 companies; a new generation was cleared every 3.4 years on median.
- None of the 35 ancestors has a recall.
- 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?
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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K182671 · printed Nov 5, 2026
Cite this page
510(k) Report. “K182671: Medi-Direct TENS Pen.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K182671
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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