510(k) · Cleared
ClearedPatch-TEA (Model TRI-21)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Transtimulation Research, Inc. · NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
Cleared on Apr 9, 2025 as substantially equivalent to K212377 (Ningbo Medkinetic Medical Device Co., Ltd., 2022) and 1 other predicate after a 138-day review. Its family tree reaches back 10 generations to 1988.
- Decided
- Apr 9, 2025
- Review
- 138 days
- Class
- Class II
- Product code
- NUH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K881114 (1988). 53 ancestors in all, the oldest K872976 (1987). No later device cites it as a predicate yet.
- Root · 10 generations backK881114 Empi Model 989, TensEmpi · 1988
- 6 generations between
- 3 generations backK182203 JKH Stimulator PlusJkh USA, LLC · 2019
- 2 generations backK191151 JKH Stimulator PlusJkh USA, LLC · 2019
- 1 generation backK231569 ManaFlexx 2 (model: MF002-RX, MF002-OTC)Manamed, Inc. · 2023
- This deviceK243613 Patch-TEA (Model TRI-21)Transtimulation Research, Inc. · 2025
Show all 10 generations
- Root · 10 generations backK881114 Empi Model 989, TensEmpi · 1988
- 9 generations backK970203 Epix VTEmpi · 1997
- 8 generations backK061650 Select Tens, Model 4600SEmpi · 2007
- 7 generations backK090922 Empi Active Transcutaneous Nerve StimulatorEmpi · 2009
- 6 generations backK121184 SensusNeurometrix, Inc. · 2012
- 5 generations backK130919 SensusNeurometrix, Inc. · 2013
- 4 generations backK140333 AscendNeurometrix, Inc. · 2014
- 3 generations backK182203 JKH Stimulator PlusJkh USA, LLC · 2019
- 2 generations backK191151 JKH Stimulator PlusJkh USA, LLC · 2019
- 1 generation backK231569 ManaFlexx 2 (model: MF002-RX, MF002-OTC)Manamed, Inc. · 2023
- This deviceK243613 Patch-TEA (Model TRI-21)Transtimulation Research, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K881114 | Empi Model 989, Tens | Empi | 1988 | — |
| −9 | K970203 | Epix VT | Empi | 1997 | — |
| −8 | K061650 | Select Tens, Model 4600S | Empi | 2007 | — |
| −7 | K090922 | Empi Active Transcutaneous Nerve Stimulator | Empi | 2009 | — |
| −6 | K121184 | Sensus | Neurometrix, Inc. | 2012 | — |
| −5 | K130919 | Sensus | Neurometrix, Inc. | 2013 | — |
| −4 | K140333 | Ascend | Neurometrix, Inc. | 2014 | — |
| −3 | K182203 | JKH Stimulator Plus | Jkh USA, LLC | 2019 | — |
| −2 | K191151 | JKH Stimulator Plus | Jkh USA, LLC | 2019 | — |
| −1 | K231569 | ManaFlexx 2 (model: MF002-RX, MF002-OTC) | Manamed, Inc. | 2023 | — |
| 0 (this device) | 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 |
| 2022 | 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 |
|---|---|---|---|
| * | K212377 | Transcutaneous Electrical Applicator (TEA), Model SNM-FDC01Summary page 5…21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K212377 Transcutaneous Electrical Applicator (TEA), Model SNM-FDC01 NUH K231569… | 2022 |
| * | K231569 | ManaFlexx 2 (model: MF002-RX, MF002-OTC)Summary page 5…Product Code K212377 Transcutaneous Electrical Applicator (TEA), Model SNM-FDC01 NUH K231569 ManaFlexx 2 (model: MF002-RX, MF002-OTC) NUH Device… | 2023 |
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 37 years and passes through 5 companies; a new generation was cleared every 3.2 years on median.
- 1 of the 53 ancestors has a recall of any class.
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. 2025, 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?
Patch-TEA is an Over-The-Counter device to be used by adults only for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, arm, and leg, due to strain from exercise or normal household work activities and suitable for home use.
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/K243613 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243613: Patch-TEA (Model TRI-21).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243613
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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