510(k) · Cleared
ClearedPainKARE
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Triowave Technologies · NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
Cleared on Nov 21, 2015 as substantially equivalent to K090042 (Newmark, Inc., 2009) and 1 other predicate after a 218-day review. Its family tree reaches back 6 generations to 1991.
- Decided
- Nov 21, 2015
- Review
- 218 days
- Class
- Class II
- Product code
- NUH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K912178 (1991). 14 ancestors in all, the oldest K880042 (1988). No later device cites it as a predicate yet.
- Root · 6 generations backK912178 Bio Tens 601, 606 and 608 (3000)Skylark Device Co., Ltd. · 1991
- 5 generations backK972244 NT2000Bio-Medical Research, Ltd. · 1998
- 4 generations backK990787 TRIO 300Ito Co., Ltd. · 1999
- 3 generations backK013167 MODEL7500 Microcurrent Tens Device, MCT-F5, MCT-F50, MCT-F500Newcare Products, LLC · 2002
- 2 generations backK090042 Painmaster MCT PatchNewmark, Inc. · 2009
- 1 generation backK130114 Painmaster MCT PatchNewmark, Inc. · 2013
- This deviceK151034 PainKARETriowave Technologies · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K912178 | Bio Tens 601, 606 and 608 (3000) | Skylark Device Co., Ltd. | 1991 | — |
| −5 | K972244 | NT2000 | Bio-Medical Research, Ltd. | 1998 | — |
| −4 | K990787 | TRIO 300 | Ito Co., Ltd. | 1999 | — |
| −3 | K013167 | MODEL7500 Microcurrent Tens Device, MCT-F5, MCT-F50, MCT-F500 | Newcare Products, LLC | 2002 | — |
| −2 | K090042 | Painmaster MCT Patch | Newmark, Inc. | 2009 | — |
| −1 | K130114 | Painmaster MCT Patch | Newmark, Inc. | 2013 | — |
| 0 (this device) | K151034 | PainKARE | Triowave Technologies | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 2 | 0 |
| 2006 | 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 |
|---|---|---|---|
| * | K090042 | Painmaster MCT PatchSummary page 4…cation' Neurology' ' Panel:' % 5.3!Predicate%Device%Information% Painmaster'MCT'Patch'(K090042;'K130114)' ' ' ' % K151034'TrioWave'Technologies''' ''''''''''''''''''Section… | 2009 |
| * | K130114 | Painmaster MCT PatchSummary page 4…Neurology' ' Panel:' % 5.3!Predicate%Device%Information% Painmaster'MCT'Patch'(K090042;'K130114)' ' ' ' % K151034'TrioWave'Technologies''' ''''''''''''''''''Section'5'–'510K… | 2013 |
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 24 years and passes through 6 companies; a new generation was cleared every 3.9 years on median.
- None of the 14 ancestors has a recall.
- 3 other devices also cite its predicate K090042.
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. 2015, 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?
The PainKARE is indicatied for Temporary relief of pain of sore and aching muscles, joints, and tissues due to strain from exercise or normal household and work activities.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151034 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151034: PainKARE.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151034
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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