510(k) · Cleared
ClearedPainmaster MCT Patch
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Newmark, Inc. · NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
Cleared on Apr 16, 2013 as substantially equivalent to K090042 (Newmark, Inc., 2009) and 1 other predicate after a 90-day review. Its family tree reaches back 5 generations to 1991. 5 later devices descend from it.
- Decided
- Apr 16, 2013
- Review
- 90 days
- Class
- Class II
- Product code
- NUH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K912178 (1991). 13 ancestors in all, the oldest K880042 (1988). 5 later devices descend from it, 4 citing it directly.
- Root · 5 generations backK912178 Bio Tens 601, 606 and 608 (3000)Skylark Device Co., Ltd. · 1991
- 4 generations backK972244 NT2000Bio-Medical Research, Ltd. · 1998
- 3 generations backK990787 TRIO 300Ito Co., Ltd. · 1999
- 2 generations backK013167 MODEL7500 Microcurrent Tens Device, MCT-F5, MCT-F50, MCT-F500Newcare Products, LLC · 2002
- 1 generation backK090042 Painmaster MCT PatchNewmark, Inc. · 2009
- This deviceK130114 Painmaster MCT PatchNewmark, Inc. · 2013
- Descendant · cites it directly · 1 of its ownK133789 Dolphin Neurostim OtcAcumed Medical, Ltd. · 2015
- Descendant · 2 generations on · 0 of its ownK182671 Medi-Direct TENS PenJkh USA, LLC · 2019
- Descendant · cites it directly · 0 of its ownK182267 PAT (Pain Alleviation Technologies)Marchan Medical, LLC · 2019
- Descendant · cites it directly · 0 of its ownK151995 Painmaster MCT PatchNewmark, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK151034 PainKARETriowave Technologies · 2015
Most influential descendants
Showing 5 of 5 · See all- K133789Dolphin Neurostim OtcAcumed Medical, Ltd. · 2015 · cites it directly1descendant
- K182671Medi-Direct TENS PenJkh USA, LLC · 2019 · 2 generations on0descendants
- K182267PAT (Pain Alleviation Technologies)Marchan Medical, LLC · 2019 · cites it directly0descendants
- K151995Painmaster MCT PatchNewmark, Inc. · 2016 · cites it directly0descendants
- K151034PainKARETriowave Technologies · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K912178 | Bio Tens 601, 606 and 608 (3000) | Skylark Device Co., Ltd. | 1991 | — |
| −4 | K972244 | NT2000 | Bio-Medical Research, Ltd. | 1998 | — |
| −3 | K990787 | TRIO 300 | Ito Co., Ltd. | 1999 | — |
| −2 | K013167 | MODEL7500 Microcurrent Tens Device, MCT-F5, MCT-F50, MCT-F500 | Newcare Products, LLC | 2002 | — |
| −1 | K090042 | Painmaster MCT Patch | Newmark, Inc. | 2009 | — |
| 0 (this device) | K130114 | Painmaster MCT Patch | Newmark, Inc. | 2013 | — |
| +1 | K133789 | Dolphin Neurostim Otc | Acumed Medical, Ltd. | 2015 | — |
| +2 | K182671 | Medi-Direct TENS Pen | Jkh USA, LLC | 2019 | — |
| +1 | K182267 | PAT (Pain Alleviation Technologies) | Marchan Medical, LLC | 2019 | — |
| +1 | K151995 | Painmaster MCT Patch | Newmark, Inc. | 2016 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2019 | 2 | 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 1…cal nerve stimulator for pain relief Regulation Number: 21 CFR 882.5890 Regulatory Class: 11 Product Code: NUH Predicate Device(s): Painmaster MCT Patch (K090042), Prizmn Medical 5000Z (K033 122) Device Description: The Painmaster MCT Patch operates in a single non-pro… | 2009 |
| * | K033122 | 5000Z System (Otc)Summary page 1…er: 21 CFR 882.5890 Regulatory Class: 11 Product Code: NUH Predicate Device(s): Painmaster MCT Patch (K090042), Prizmn Medical 5000Z (K033 122) Device Description: The Painmaster MCT Patch operates in a single non-programmable microcurrent mode, delivering a pulsed monop… | 2004 |
What descends from it? (5)
4 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 22 years and passes through 5 companies; a new generation was cleared every 3.9 years on median.
- None of the 13 ancestors has a recall.
- Of its descendants, K133789 (Acumed Medical, Ltd., 2015) has gone furthest, with 1 descendant of its own.
- 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. 2013, 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 Painmaster MOT Patch is indicated for temporary relief of pain associated with sore and aching muscles in the upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130114 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130114: Painmaster MCT Patch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130114
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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