510(k) · Cleared
ClearedMHD Tens
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Minghuangda Electronic Co., Ltd. · NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
Cleared on Jun 19, 2019 as substantially equivalent to K143268 (Shenzhen As-Tec Technology Co., Ltd., 2015) after a 146-day review. Its family tree reaches back 1 generation to 2015. 3 later devices descend from it.
- Decided
- Jun 19, 2019
- Review
- 146 days
- Class
- Class II
- Product code
- NUH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K143268 (2015). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK143268 Tens and Powered Muscle StimulatorShenzhen As-Tec Technology Co., Ltd. · 2015
- This deviceK190115 MHD TensMinghuangda Electronic Co., Ltd. · 2019
- Descendant · cites it directly · 1 of its ownK200727 TENS and Muscle StimulatorShenzhen Astec Technology Co., Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK241678 TENS & EMS Stimulator (MHD-1083)Shenzhen Minghuangda Electronics Co., Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK201845 Portable Electro-Stimulation Therapy Device, Model: LGT-232(US)Guangzhou Longest Science & Technology Co., Ltd. · 2020
Most influential descendants
Showing 3 of 3 · See all- K200727TENS and Muscle StimulatorShenzhen Astec Technology Co., Ltd. · 2020 · cites it directly1descendant
- K241678TENS & EMS Stimulator (MHD-1083)Shenzhen Minghuangda Electronics Co., Ltd. · 2024 · cites it directly0descendants
- K201845Portable Electro-Stimulation Therapy Device, Model: LGT-232(US)Guangzhou Longest Science & Technology Co., Ltd. · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K143268 | Tens and Powered Muscle Stimulator | Shenzhen As-Tec Technology Co., Ltd. | 2015 | — |
| 0 (this device) | K190115 | MHD Tens | Minghuangda Electronic Co., Ltd. | 2019 | — |
| +1 | K200727 | TENS and Muscle Stimulator | Shenzhen Astec Technology Co., Ltd. | 2020 | — |
| +1 | K241678 | TENS & EMS Stimulator (MHD-1083) | Shenzhen Minghuangda Electronics Co., Ltd. | 2024 | — |
| +2 | K201845 | Portable Electro-Stimulation Therapy Device, Model: LGT-232(US) | Guangzhou Longest Science & Technology Co., Ltd. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 2 | 0 |
| 2024 | 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? (1)
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.
What descends from it? (3)
2 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?
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. 2019, 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?
Transcutaneous Electrical Nerve Stimulation (Program 2, 3, 4, 6, 8, 9):
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
Powered Muscle Stimulation (Program 1, 5, 7, 10, 11, 12):
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190115 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190115: MHD Tens.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190115
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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