510(k) · Cleared
ClearedElectronic Pulse Stimulator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Leading Perfection Technology Co., Ltd. · NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
Cleared on Oct 11, 2019 as substantially equivalent to K151035 (Philips Consumer Lifestyle, 2015) and 2 other predicates after a 288-day review. Its family tree reaches back 7 generations to 1994.
- Decided
- Oct 11, 2019
- Review
- 288 days
- Class
- Class II
- Product code
- NUH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K940301 (1994). 17 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK940301 Compex 2Biodex Medical Systems, Inc. · 1994
- 6 generations backK011880 Compex SportCompex S.A. · 2002
- 5 generations backK060846 Therapeutic Massage CompanionEndurance Therapeutics · 2007
- 4 generations backK110068 Model PM3030Omron Healthcare, Inc. · 2011
- 3 generations backK132993 Counter Otc Tens DeviceCounter Scientific Development (Gz), Ltd. · 2014
- 2 generations backK150386 Tyece OTC TENS DeviceTyece, Ltd. · 2015
- 1 generation backK171803 HIVOX OTC Electrical StimulatorHivox Biotek, Inc. · 2017
- This deviceK183674 Electronic Pulse StimulatorShenzhen Leading Perfection Technology Co., Ltd. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K940301 | Compex 2 | Biodex Medical Systems, Inc. | 1994 | — |
| −6 | K011880 | Compex Sport | Compex S.A. | 2002 | — |
| −5 | K060846 | Therapeutic Massage Companion | Endurance Therapeutics | 2007 | — |
| −4 | K110068 | Model PM3030 | Omron Healthcare, Inc. | 2011 | — |
| −3 | K132993 | Counter Otc Tens Device | Counter Scientific Development (Gz), Ltd. | 2014 | — |
| −2 | K150386 | Tyece OTC TENS Device | Tyece, Ltd. | 2015 | — |
| −1 | K171803 | HIVOX OTC Electrical Stimulator | Hivox Biotek, Inc. | 2017 | — |
| 0 (this device) | K183674 | Electronic Pulse Stimulator | Shenzhen Leading Perfection Technology Co., Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 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? (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 |
|---|---|---|---|
| * | K151035 | PulseReliefSummary page 4…e Device Applicant Predicate Device 510(k) Number Approval Date Philips Consumer (Primary): K151035 July 21,2015 Lifstyle PulseRelief HIVOX OTC Electrical HIVOX… | 2015 |
| * | K171803 | HIVOX OTC Electrical StimulatorSummary page 4…uly 21,2015 Lifstyle PulseRelief HIVOX OTC Electrical HIVOX BIOTEK INC. K171803 November 29, 2017 Stimulator /SEM44 Shenzhen OSTO Health Expert Electronic… | 2017 |
| * | K133929 | Health Expert Elctronic StimulatorSummary page 4…November 29, 2017 Stimulator /SEM44 Shenzhen OSTO Health Expert Electronic Technology Company Stimulator, Model AST- K133929 November 12, 2014 Limited 300C and AST-300D… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
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 25 years and passes through 8 companies; a new generation was cleared every 2.4 years on median.
- None of the 17 ancestors has a recall.
- 6 other devices also cite its predicate K151035.
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?
Mode 1 (PMS):
To be used for stimulating healthy muscles in order to improve and facilitate muscle performance.
Mode 2 (TENS):
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183674 · printed Nov 5, 2026
Cite this page
510(k) Report. “K183674: Electronic Pulse Stimulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K183674
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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