510(k) · Cleared
ClearedOtc Electrical Stimulator (MT9001), Otc Tens Device (LT3060)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Dongdixin Technology Co., Ltd. · NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
Cleared on Sep 16, 2013 after a 178-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 45 later devices descend from it.
- Decided
- Sep 16, 2013
- Review
- 178 days
- Class
- Class II
- Product code
- NUH
- Recalls
- None
- Predicates
- 0
45 later devices descend from it, 7 citing it directly.
- This deviceK130802 Otc Electrical Stimulator (MT9001), Otc Tens Device (LT3060)Shenzhen Dongdixin Technology Co., Ltd. · 2013
- Descendant · cites it directly · 21 of its ownK171803 HIVOX OTC Electrical StimulatorHivox Biotek, Inc. · 2017
- Descendant · cites it directly · 20 of its ownK151035 PulseReliefPhilips Consumer Lifestyle · 2015
- Descendant · 2 generations on · 8 of its ownK190347 HIVOX OTC Electrical StimulatorHivox Biotek, Inc. · 2019
- Descendant · 2 generations on · 5 of its ownK172079 AvailOmron Healthcare, Inc. · 2017
- Descendant · 3 generations on · 4 of its ownK203574 HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical…Hivox Biotek, Inc. · 2021
Showing 5 of 45 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 45 · See all- K171803HIVOX OTC Electrical StimulatorHivox Biotek, Inc. · 2017 · cites it directly21descendants
- K151035PulseReliefPhilips Consumer Lifestyle · 2015 · cites it directly20descendants
- K190347HIVOX OTC Electrical StimulatorHivox Biotek, Inc. · 2019 · 2 generations on8descendants
- K172079AvailOmron Healthcare, Inc. · 2017 · 2 generations on5descendants
- K203574HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2Hivox Biotek, Inc. · 2021 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K130802 | Otc Electrical Stimulator (MT9001), Otc Tens Device (LT3060) | Shenzhen Dongdixin Technology Co., Ltd. | 2013 | — |
| +1 | K171803 | HIVOX OTC Electrical Stimulator | Hivox Biotek, Inc. | 2017 | — |
| +1 | K151035 | PulseRelief | Philips Consumer Lifestyle | 2015 | — |
| +2 | K190347 | HIVOX OTC Electrical Stimulator | Hivox Biotek, Inc. | 2019 | — |
| +2 | K172079 | Avail | Omron Healthcare, Inc. | 2017 | — |
| +3 | K203574 | HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2 | Hivox Biotek, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 6 | 0 |
| 2018 | 5 | 0 |
| 2019 | 7 | 0 |
| 2020 | 2 | 0 |
| 2021 | 5 | 0 |
| 2022 | 7 | 0 |
| 2023 | 2 | 0 |
| 2024 | 5 | 0 |
| 2025 | 3 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (45)
See all 457 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171803 | HIVOX OTC Electrical Stimulator | 2017 | 21 |
| K151035 | PulseRelief | 2015 | 20 |
| K251958 | VEINOPLUS Back | 2025 | 0 |
| K232439 | Electrical Stimulator System | 2024 | 0 |
| K220573 | Noodle | 2022 | 0 |
| K200838 | Tyece OTC TENS Model | 2020 | 0 |
| K180956 | Electrical Stimulator - Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator… | 2018 | 0 |
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?
- Of its descendants, K171803 (Hivox Biotek, Inc., 2017) has gone furthest, with 21 descendants of its own.
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?
MT9001 OTC TENS/EMS stimulator TENS: The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. EMS: The device is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance. LT3060 OTC TENS stimulator TENS: The…
Read the full statement (112 words)
MT9001 OTC TENS/EMS stimulator
TENS: The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
EMS: The device is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.
LT3060 OTC TENS stimulator
TENS: The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K130802 · printed Nov 3, 2026
Cite this page
510(k) Report. “K130802: Otc Electrical Stimulator (MT9001), Otc Tens Device (LT3060).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K130802
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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