510(k) · Cleared
ClearedHIVOX OTC Electrical Stimulator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hivox Biotek, Inc. · NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
Cleared on Nov 29, 2017 as substantially equivalent to K130802 (Shenzhen Dongdixin Technology Co., Ltd., 2013) and 1 other predicate after a 163-day review. Its family tree reaches back 6 generations to 1994. 21 later devices descend from it.
- Decided
- Nov 29, 2017
- Review
- 163 days
- Class
- Class II
- Product code
- NUH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K940301 (1994). 9 ancestors in all. 21 later devices descend from it, 11 citing it directly.
- Root · 6 generations backK940301 Compex 2Biodex Medical Systems, Inc. · 1994
- 5 generations backK011880 Compex SportCompex S.A. · 2002
- 4 generations backK060846 Therapeutic Massage CompanionEndurance Therapeutics · 2007
- 3 generations backK110068 Model PM3030Omron Healthcare, Inc. · 2011
- 2 generations backK132993 Counter Otc Tens DeviceCounter Scientific Development (Gz), Ltd. · 2014
- 1 generation backK150386 Tyece OTC TENS DeviceTyece, Ltd. · 2015
- This deviceK171803 HIVOX OTC Electrical StimulatorHivox Biotek, Inc. · 2017
- Descendant · cites it directly · 8 of its ownK190347 HIVOX OTC Electrical StimulatorHivox Biotek, Inc. · 2019
- Descendant · 2 generations on · 4 of its ownK203574 HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical…Hivox Biotek, Inc. · 2021
- Descendant · cites it directly · 3 of its ownK202866 TENS & EMS DeviceShenzhen Jian Feng Electronic Technology Co., Ltd. · 2021
- Descendant · 2 generations on · 1 of its ownK213741 TENS & EMS DEVICE (Model: FM-B2403A)Shenzhen Jian Feng Electronic Technology Co., Ltd. · 2022
- Descendant · 2 generations on · 1 of its ownK200694 Perfect EMSTenscare, Ltd. · 2021
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K190347HIVOX OTC Electrical StimulatorHivox Biotek, Inc. · 2019 · cites it directly8descendants
- K203574HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2Hivox Biotek, Inc. · 2021 · 2 generations on4descendants
- K202866TENS & EMS DeviceShenzhen Jian Feng Electronic Technology Co., Ltd. · 2021 · cites it directly3descendants
- K213741TENS & EMS DEVICE (Model: FM-B2403A)Shenzhen Jian Feng Electronic Technology Co., Ltd. · 2022 · 2 generations on1descendant
- K200694Perfect EMSTenscare, Ltd. · 2021 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K940301 | Compex 2 | Biodex Medical Systems, Inc. | 1994 | — |
| −5 | K011880 | Compex Sport | Compex S.A. | 2002 | — |
| −4 | K060846 | Therapeutic Massage Companion | Endurance Therapeutics | 2007 | — |
| −3 | K110068 | Model PM3030 | Omron Healthcare, Inc. | 2011 | — |
| −2 | K132993 | Counter Otc Tens Device | Counter Scientific Development (Gz), Ltd. | 2014 | — |
| −1 | K150386 | Tyece OTC TENS Device | Tyece, Ltd. | 2015 | — |
| 0 (this device) | K171803 | HIVOX OTC Electrical Stimulator | Hivox Biotek, Inc. | 2017 | — |
| +1 | K190347 | HIVOX OTC Electrical Stimulator | Hivox Biotek, Inc. | 2019 | — |
| +2 | K203574 | HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2 | Hivox Biotek, Inc. | 2021 | — |
| +1 | K202866 | TENS & EMS Device | Shenzhen Jian Feng Electronic Technology Co., Ltd. | 2021 | — |
| +2 | K213741 | TENS & EMS DEVICE (Model: FM-B2403A) | Shenzhen Jian Feng Electronic Technology Co., Ltd. | 2022 | — |
| +2 | K200694 | Perfect EMS | Tenscare, Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2021 | 5 | 0 |
| 2022 | 4 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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? (2)
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 |
|---|---|---|---|
| * | K130802 | Otc Electrical Stimulator (MT9001), Otc Tens Device (LT3060)Summary page 5…oduct Code: NGX Regulation number: 882.5890 Device Class: II 510(k) Number: K130802 Predicate Device Name: Tyece OTC TENS Device Model Number: SEM44 Ma… | 2013 |
| * | K150386 | Tyece OTC TENS DeviceSummary page 5…n Product Code: NUH Regulation number: 882.5890 Device Class: II 510(k) Number: K150386 5.6 Intended Use/ Indications for Use of the Device HIVOX OTC Electrical Stimulator, SEM44 – TENS: The device is designed to… | 2015 |
What descends from it? (21)
See all 2111 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190347 | HIVOX OTC Electrical Stimulator | 2019 | 8 |
| K202866 | TENS & EMS Device | 2021 | 3 |
| K253896 | TENS/EMS device (GUSE01) | 2026 | 0 |
| K242460 | Progenix Select Stim | 2025 | 0 |
| K242815 | Pocket Tens (EP-300) | 2024 | 0 |
| K241119 | Transcutaneous Electrical Nerve Stimulator (K6106) | 2024 | 0 |
| K232439 | Electrical Stimulator System | 2024 | 0 |
| K200558 | Smart Neck Stimulator | 2021 | 0 |
| K183674 | Electronic Pulse Stimulator | 2019 | 0 |
| K183103 | EMS Belt (Model MC0485) | 2019 | 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?
- The line of descent spans 23 years and passes through 7 companies; a new generation was cleared every 4.0 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K190347 (Hivox Biotek, Inc., 2019) has gone furthest, with 8 descendants of its own.
- 6 other devices also cite its predicate K130802.
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. 2017, 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?
HIVOX OTC Electrical Stimulator, SEM44 – 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), lower extremities (leg), abdomen and bottom 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. HIVOX OTC…
Read the full statement (120 words)
HIVOX OTC Electrical Stimulator, SEM44 –
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), lower extremities (leg), abdomen and bottom 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.
HIVOX OTC Electrical Stimulator, SEM44-1 –
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), 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/K171803 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171803: HIVOX OTC Electrical Stimulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171803
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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