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 May 6, 2009 as substantially equivalent to K013167 (Newcare Products, LLC, 2002) and 2 other predicates after a 120-day review. Its family tree reaches back 4 generations to 1991. 11 later devices descend from it.
- Decided
- May 6, 2009
- Review
- 120 days
- Class
- Class II
- Product code
- NUH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K912178 (1991). 12 ancestors in all, the oldest K880042 (1988). 11 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK912178 Bio Tens 601, 606 and 608 (3000)Skylark Device Co., Ltd. · 1991
- 3 generations backK972244 NT2000Bio-Medical Research, Ltd. · 1998
- 2 generations backK990787 TRIO 300Ito Co., Ltd. · 1999
- 1 generation backK013167 MODEL7500 Microcurrent Tens Device, MCT-F5, MCT-F50, MCT-F500Newcare Products, LLC · 2002
- This deviceK090042 Painmaster MCT PatchNewmark, Inc. · 2009
- Descendant · cites it directly · 5 of its ownK130114 Painmaster MCT PatchNewmark, Inc. · 2013
- Descendant · cites it directly · 4 of its ownK120500 The Pain Pilot (a.K.a Pain Pilot)Hollywog, LLC · 2012
- Descendant · 2 generations on · 2 of its ownK152852 ALEVE Direct Therapy (ALEVE Direct Therapy TENS device)Bayer Healthcare, LLC · 2015
- Descendant · 2 generations on · 1 of its ownK133789 Dolphin Neurostim OtcAcumed Medical, Ltd. · 2015
- Descendant · 3 generations on · 0 of its ownK190009 Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S)Hong Qiangxing (Shenzhen) Electronics Limited · 2019
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K130114Painmaster MCT PatchNewmark, Inc. · 2013 · cites it directly5descendants
- K120500The Pain Pilot (a.K.a Pain Pilot)Hollywog, LLC · 2012 · cites it directly4descendants
- K152852ALEVE Direct Therapy (ALEVE Direct Therapy TENS device)Bayer Healthcare, LLC · 2015 · 2 generations on2descendants
- K133789Dolphin Neurostim OtcAcumed Medical, Ltd. · 2015 · 2 generations on1descendant
- K190009Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S)Hong Qiangxing (Shenzhen) Electronics Limited · 2019 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K912178 | Bio Tens 601, 606 and 608 (3000) | Skylark Device Co., Ltd. | 1991 | — |
| −3 | K972244 | NT2000 | Bio-Medical Research, Ltd. | 1998 | — |
| −2 | K990787 | TRIO 300 | Ito Co., Ltd. | 1999 | — |
| −1 | K013167 | MODEL7500 Microcurrent Tens Device, MCT-F5, MCT-F50, MCT-F500 | Newcare Products, LLC | 2002 | — |
| 0 (this device) | K090042 | Painmaster MCT Patch | Newmark, Inc. | 2009 | — |
| +1 | K130114 | Painmaster MCT Patch | Newmark, Inc. | 2013 | — |
| +1 | K120500 | The Pain Pilot (a.K.a Pain Pilot) | Hollywog, LLC | 2012 | — |
| +2 | K152852 | ALEVE Direct Therapy (ALEVE Direct Therapy TENS device) | Bayer Healthcare, LLC | 2015 | — |
| +2 | K133789 | Dolphin Neurostim Otc | Acumed Medical, Ltd. | 2015 | — |
| +3 | K190009 | Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S) | Hong Qiangxing (Shenzhen) Electronics Limited | 2019 | — |
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 |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 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 |
|---|---|---|---|
| * | K013167 | MODEL7500 Microcurrent Tens Device, MCT-F5, MCT-F50, MCT-F500Summary page 1…r pain relief Classification Name: Stimulator, nerve, transcutaneous, over-the-counter Regulation Number: 21 CFR 882.5890 Product Code: NUH Predicate Devices: K01 3 167 - Model 7500 Microcurrent TENS Device (Version F5) (same device as subject for prescription use)… | 2002 |
| * | K033122 | 5000Z System (Otc)Summary page 1…Devices: K01 3 167 - Model 7500 Microcurrent TENS Device (Version F5) (same device as subject for prescription use) K033 122 - Prizm Medical 5000Z System (OTC), and K060222 - Gemore Technology Low Back Pain Relief System… | 2004 |
| * | K060222 | Low Back Pain Relief System /Models GM310PP,GM320PP,GM321PP, and GM330PPSummary page 1…F5) (same device as subject for prescription use) K033 122 - Prizm Medical 5000Z System (OTC), and K060222 - Gemore Technology Low Back Pain Relief System (OTC). Intended Use The Painmaster M… | 2006 |
What descends from it? (11)
See all 114 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 18 years and passes through 5 companies; a new generation was cleared every 6.3 years on median.
- None of the 12 ancestors has a recall.
- Of its descendants, K130114 (Newmark, Inc., 2013) has gone furthest, with 5 descendants of its own.
- 2 other devices also cite its predicate K013167.
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. 2009, 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 MCT Patch is indicated for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090042 · printed Nov 4, 2026
Cite this page
510(k) Report. “K090042: Painmaster MCT Patch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090042
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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