510(k) · Cleared
ClearedMODEL7500 Microcurrent Tens Device, MCT-F5, MCT-F50, MCT-F500
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Newcare Products, LLC · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Cleared on Jan 30, 2002 as substantially equivalent to K003507 (Healthonics, Inc., 2001) and 1 other predicate after a 131-day review. Its family tree reaches back 3 generations to 1991. 13 later devices descend from it.
- Decided
- Jan 30, 2002
- Review
- 131 days
- Class
- Class II
- Product code
- GZJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K912178 (1991). 8 ancestors in all, the oldest K880042 (1988). 13 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK912178 Bio Tens 601, 606 and 608 (3000)Skylark Device Co., Ltd. · 1991
- 2 generations backK972244 NT2000Bio-Medical Research, Ltd. · 1998
- 1 generation backK990787 TRIO 300Ito Co., Ltd. · 1999
- This deviceK013167 MODEL7500 Microcurrent Tens Device, MCT-F5, MCT-F50, MCT-F500Newcare Products, LLC · 2002
- Descendant · cites it directly · 11 of its ownK090042 Painmaster MCT PatchNewmark, Inc. · 2009
- Descendant · 2 generations on · 5 of its ownK130114 Painmaster MCT PatchNewmark, Inc. · 2013
- Descendant · 2 generations on · 4 of its ownK120500 The Pain Pilot (a.K.a Pain Pilot)Hollywog, LLC · 2012
- Descendant · 3 generations on · 2 of its ownK152852 ALEVE Direct Therapy (ALEVE Direct Therapy TENS device)Bayer Healthcare, LLC · 2015
- Descendant · 3 generations on · 1 of its ownK133789 Dolphin Neurostim OtcAcumed Medical, Ltd. · 2015
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K090042Painmaster MCT PatchNewmark, Inc. · 2009 · cites it directly11descendants
- K130114Painmaster MCT PatchNewmark, Inc. · 2013 · 2 generations on5descendants
- K120500The Pain Pilot (a.K.a Pain Pilot)Hollywog, LLC · 2012 · 2 generations on4descendants
- K152852ALEVE Direct Therapy (ALEVE Direct Therapy TENS device)Bayer Healthcare, LLC · 2015 · 3 generations on2descendants
- K133789Dolphin Neurostim OtcAcumed Medical, Ltd. · 2015 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K912178 | Bio Tens 601, 606 and 608 (3000) | Skylark Device Co., Ltd. | 1991 | — |
| −2 | K972244 | NT2000 | Bio-Medical Research, Ltd. | 1998 | — |
| −1 | K990787 | TRIO 300 | Ito Co., Ltd. | 1999 | — |
| 0 (this device) | K013167 | MODEL7500 Microcurrent Tens Device, MCT-F5, MCT-F50, MCT-F500 | Newcare Products, LLC | 2002 | — |
| +1 | K090042 | Painmaster MCT Patch | Newmark, Inc. | 2009 | — |
| +2 | K130114 | Painmaster MCT Patch | Newmark, Inc. | 2013 | — |
| +2 | K120500 | The Pain Pilot (a.K.a Pain Pilot) | Hollywog, LLC | 2012 | — |
| +3 | K152852 | ALEVE Direct Therapy (ALEVE Direct Therapy TENS device) | Bayer Healthcare, LLC | 2015 | — |
| +3 | K133789 | Dolphin Neurostim Otc | Acumed Medical, Ltd. | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 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 GZJ? 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 GZJ device
- #1 K252767 actiTENS miniscore 13.1 · 9 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 |
|---|---|---|---|
| * | K003507 | Medrelief | 2001 |
| * | K990787 | TRIO 300Summary page 1…ect to some characteristics to the Advance Medequip Model 850 Microcurrent TENS device, 510(k) number unknown, but the device is currently marketed, and to the Ito Trio (K990787). DEVICE DESCRIPTION A number of TENS and microcurrent devices have been cleared for marketing by FDA that have just a few disc… | 1999 |
| * | — | Advance Medequip Model 850 Microcurrent TENS device Named without a submission number |
What descends from it? (13)
See all 133 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 11 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K090042 (Newmark, Inc., 2009) has gone furthest, with 11 descendants of its own.
- 1 other device also cites its predicate K003507.
How does its category compare?
All GZJ devicesGZJ Stimulator, Nerve, Transcutaneous, For Pain Relief: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GZJ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GZJ
207in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GZJ
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GZJ
13in 2025
MAUDE reports naming product code GZJ, 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 | 13 | 223 | 4 | 4 |
| 2008 | 11 | 136 | 1 | 45 |
| 2009 | 16 | 155 | 0 | 17 |
| 2010 | 5 | 232 | 0 | 22 |
| 2011 | 5 | 168 | 1 | 22 |
| 2012 | 12 | 154 | 0 | 20 |
| 2013 | 2 | — | 0 | 10 |
| 2014 | 4 | 344 | 0 | 23 |
| 2015 | 3 | 202 | 0 | 18 |
| 2016 | 3 | 163 | 0 | 32 |
| 2017 | 3 | 113 | 0 | 58 |
| 2018 | 2 | — | 0 | 21 |
| 2019 | 3 | 156 | 0 | 7 |
| 2020 | 4 | 183 | 0 | 10 |
| 2021 | 3 | 231 | 0 | 5 |
| 2022 | 4 | 175 | 0 | 4 |
| 2023 | 1 | — | 0 | 39 |
| 2024 | 3 | 207 | 0 | 12 |
| 2025 | 1 | — | 0 | 13 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The subject device is intended to be used for the symptomatic relief of chronic intractable pain.
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/K013167 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013167: MODEL7500 Microcurrent Tens Device, MCT-F5, MCT-F50, MCT-F500.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013167
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026