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 Mar 15, 2019 as substantially equivalent to K171803 (Hivox Biotek, Inc., 2017) after a 29-day review. Its family tree reaches back 7 generations to 1994. 8 later devices descend from it.
- Decided
- Mar 15, 2019
- Review
- 29 days
- Class
- Class II
- Product code
- NUH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K940301 (1994). 10 ancestors in all. 8 later devices descend from it, 3 citing it directly.
- 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 deviceK190347 HIVOX OTC Electrical StimulatorHivox Biotek, Inc. · 2019
- Descendant · cites it directly · 4 of its ownK203574 HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical…Hivox Biotek, Inc. · 2021
- Descendant · cites it directly · 1 of its ownK200694 Perfect EMSTenscare, Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK242460 Progenix Select StimProgenix, LLC · 2025
- Descendant · 2 generations on · 0 of its ownK230926 Ova+ (K-OVAP-USA)Tenscare, Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK223308 Heating Tens/Ems, FT-810RHivox Biotek, Inc. · 2023
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K203574HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2Hivox Biotek, Inc. · 2021 · cites it directly4descendants
- K200694Perfect EMSTenscare, Ltd. · 2021 · cites it directly1descendant
- K242460Progenix Select StimProgenix, LLC · 2025 · cites it directly0descendants
- K230926Ova+ (K-OVAP-USA)Tenscare, Ltd. · 2023 · 2 generations on0descendants
- K223308Heating Tens/Ems, FT-810RHivox Biotek, Inc. · 2023 · 2 generations on0descendants
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) | K190347 | HIVOX OTC Electrical Stimulator | Hivox Biotek, Inc. | 2019 | — |
| +1 | K203574 | HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2 | Hivox Biotek, Inc. | 2021 | — |
| +1 | K200694 | Perfect EMS | Tenscare, Ltd. | 2021 | — |
| +1 | K242460 | Progenix Select Stim | Progenix, LLC | 2025 | — |
| +2 | K230926 | Ova+ (K-OVAP-USA) | Tenscare, Ltd. | 2023 | — |
| +2 | K223308 | Heating Tens/Ems, FT-810R | Hivox Biotek, Inc. | 2023 | — |
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 |
|---|---|---|
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2025 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K171803 | HIVOX OTC Electrical StimulatorSummary page 5…1) 882.5890 2) 890.5850 Device Class: II 510(k) Number: K171803 6.6 Intended Use/ Indications for Use of the Device HIVOX OTC Electrical Stimulator, EM49-1 – TENS: The device is designe… | 2017 |
What descends from it? (8)
3 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 25 years and passes through 7 companies; a new generation was cleared every 2.4 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K203574 (Hivox Biotek, Inc., 2021) has gone furthest, with 4 descendants of its own.
- 10 other devices also cite its predicate K171803.
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?
HIVOX OTC Electrical Stimulator, EM49-1 – 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. HIVOX OTC Electrical Stimulator, EM49-2 – TENS: The device is designed to be used for temporary relief of pain associated with sore and…
Read the full statement (120 words)
HIVOX OTC Electrical Stimulator, EM49-1 –
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.
HIVOX OTC Electrical Stimulator, EM49-2 –
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190347 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190347: 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/K190347
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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