510(k) · Cleared
ClearedHIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2
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 Mar 10, 2021 as substantially equivalent to K162517 (Jkh Health Co., Ltd., 2017) and 1 other predicate after a 93-day review. Its family tree reaches back 8 generations to 1994. 4 later devices descend from it.
- Decided
- Mar 10, 2021
- Review
- 93 days
- Class
- Class II
- Product code
- NUH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K940301 (1994). 26 ancestors in all, the oldest K880042 (1988). 4 later devices descend from it, 4 citing it directly.
- Root · 8 generations backK940301 Compex 2Biodex Medical Systems, Inc. · 1994
- 7 generations backK011880 Compex SportCompex S.A. · 2002
- 6 generations backK060846 Therapeutic Massage CompanionEndurance Therapeutics · 2007
- 5 generations backK110068 Model PM3030Omron Healthcare, Inc. · 2011
- 4 generations backK132993 Counter Otc Tens DeviceCounter Scientific Development (Gz), Ltd. · 2014
- 3 generations backK150386 Tyece OTC TENS DeviceTyece, Ltd. · 2015
- 2 generations backK171803 HIVOX OTC Electrical StimulatorHivox Biotek, Inc. · 2017
- 1 generation backK190347 HIVOX OTC Electrical StimulatorHivox Biotek, Inc. · 2019
- This deviceK203574 HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical…Hivox Biotek, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK223308 Heating Tens/Ems, FT-810RHivox Biotek, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK221251 Ems Foot Stimulator (model: HK701, HK701A, HK701B, HK701C)Guangzhou Huakai Electronic Technology Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK213091 Well-Life TENS/EMS/Heating StimulatorWell-Life Healthcare Limited · 2022
- Descendant · cites it directly · 0 of its ownK212918 Heat StimPlusFamidoc Technology Co., Ltd. · 2021
Most influential descendants
Showing 4 of 4 · See all- K223308Heating Tens/Ems, FT-810RHivox Biotek, Inc. · 2023 · cites it directly0descendants
- K221251Ems Foot Stimulator (model: HK701, HK701A, HK701B, HK701C)Guangzhou Huakai Electronic Technology Co., Ltd. · 2022 · cites it directly0descendants
- K213091Well-Life TENS/EMS/Heating StimulatorWell-Life Healthcare Limited · 2022 · cites it directly0descendants
- K212918Heat StimPlusFamidoc Technology Co., Ltd. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K940301 | Compex 2 | Biodex Medical Systems, Inc. | 1994 | — |
| −7 | K011880 | Compex Sport | Compex S.A. | 2002 | — |
| −6 | K060846 | Therapeutic Massage Companion | Endurance Therapeutics | 2007 | — |
| −5 | K110068 | Model PM3030 | Omron Healthcare, Inc. | 2011 | — |
| −4 | K132993 | Counter Otc Tens Device | Counter Scientific Development (Gz), Ltd. | 2014 | — |
| −3 | K150386 | Tyece OTC TENS Device | Tyece, Ltd. | 2015 | — |
| −2 | K171803 | HIVOX OTC Electrical Stimulator | Hivox Biotek, Inc. | 2017 | — |
| −1 | K190347 | HIVOX OTC Electrical Stimulator | Hivox Biotek, Inc. | 2019 | — |
| 0 (this device) | K203574 | HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2 | Hivox Biotek, Inc. | 2021 | — |
| +1 | K223308 | Heating Tens/Ems, FT-810R | Hivox Biotek, Inc. | 2023 | — |
| +1 | K221251 | Ems Foot Stimulator (model: HK701, HK701A, HK701B, HK701C) | Guangzhou Huakai Electronic Technology Co., Ltd. | 2022 | — |
| +1 | K213091 | Well-Life TENS/EMS/Heating Stimulator | Well-Life Healthcare Limited | 2022 | — |
| +1 | K212918 | Heat StimPlus | Famidoc Technology Co., Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1991 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2007 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K162517 | Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13Summary page 4…3) Physical Medicine Device class: II 5. Identification of the Predicate Device #1 510(k) number: K162517 Proprietary/Trade name: Electrical Pulse Stimulator Models: PL-029K13 Classification… | 2017 |
| * | K190347 | HIVOX OTC Electrical StimulatorSummary page 5…view panel: Neurology Device class: II 6. Identification of the Predicate Device #2 510(k) number: K190347 Proprietary/Trade name: HIVOX OTC Electrical Stimulator Models: EM49-1, EM49-2 Classi… | 2019 |
What descends from it? (4)
4 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 27 years and passes through 7 companies; a new generation was cleared every 2.4 years on median.
- None of the 26 ancestors has a recall.
- Of its descendants, K223308 (Hivox Biotek, Inc., 2023) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K162517.
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. 2021, 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, EM59-1 TENS: This function is designated 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. SH: This function is designed to be used for temporary relief of minor aches and pains. HIVOX OTC Electrical Stimulator, EM59-2 TENS: This function is…
Read the full statement (144 words)
HIVOX OTC Electrical Stimulator, EM59-1
TENS: This function is designated 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.
SH: This function is designed to be used for temporary relief of minor aches and pains.
HIVOX OTC Electrical Stimulator, EM59-2
TENS: This function is designated 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.
EMS: This function is designed to be used for stimulating healthy muscles in order to improve and facilitate muscle performance.
SH: This function is designed to be used for temporary relief of minor aches and pains.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203574 · printed Nov 5, 2026
Cite this page
510(k) Report. “K203574: HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K203574
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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