510(k) · Cleared
ClearedHIVOX OTC Electrical Stimulator, FT610-B
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 Oct 15, 2021 as substantially equivalent to K162517 (Jkh Health Co., Ltd., 2017) after a 162-day review. Its family tree reaches back 6 generations to 1991. 3 later devices descend from it.
- Decided
- Oct 15, 2021
- Review
- 162 days
- Class
- Class II
- Product code
- NUH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K912178 (1991). 15 ancestors in all, the oldest K880042 (1988). 3 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK912178 Bio Tens 601, 606 and 608 (3000)Skylark Device Co., Ltd. · 1991
- 5 generations backK972244 NT2000Bio-Medical Research, Ltd. · 1998
- 4 generations backK990787 TRIO 300Ito Co., Ltd. · 1999
- 3 generations backK023231 Elfcare Device, Models 314A Through 314GMediseb, Ltd. · 2003
- 2 generations backK070299 Ezfit Digital Heating Tens (Model NO.: HR-661/UC-101)Ezfit Technology, Inc. · 2007
- 1 generation backK162517 Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13Jkh Health Co., Ltd. · 2017
- This deviceK211403 HIVOX OTC Electrical Stimulator, FT610-BHivox Biotek, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK232675 Heating Tens, FT-615Hivox Biotek, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK223151 Nu-beca Transcutaneous Electrical Nerve StimulationNu-Beca & Maxcellent Co. · 2023
- Descendant · cites it directly · 0 of its ownK223308 Heating Tens/Ems, FT-810RHivox Biotek, Inc. · 2023
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K912178 | Bio Tens 601, 606 and 608 (3000) | Skylark Device Co., Ltd. | 1991 | — |
| −5 | K972244 | NT2000 | Bio-Medical Research, Ltd. | 1998 | — |
| −4 | K990787 | TRIO 300 | Ito Co., Ltd. | 1999 | — |
| −3 | K023231 | Elfcare Device, Models 314A Through 314G | Mediseb, Ltd. | 2003 | — |
| −2 | K070299 | Ezfit Digital Heating Tens (Model NO.: HR-661/UC-101) | Ezfit Technology, Inc. | 2007 | — |
| −1 | K162517 | Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13 | Jkh Health Co., Ltd. | 2017 | — |
| 0 (this device) | K211403 | HIVOX OTC Electrical Stimulator, FT610-B | Hivox Biotek, Inc. | 2021 | — |
| +1 | K232675 | Heating Tens, FT-615 | Hivox Biotek, Inc. | 2023 | — |
| +1 | K223151 | Nu-beca Transcutaneous Electrical Nerve Stimulation | Nu-Beca & Maxcellent Co. | 2023 | — |
| +1 | K223308 | Heating Tens/Ems, FT-810R | Hivox Biotek, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2005 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 3 | 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 |
|---|---|---|---|
| * | K162517 | Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13Summary page 4…e: NUH Regulation Number: 21 CFR 882.5890 Device Class: II 5. Identification of the Predicate Device #1 510(k) Number: K162517 Manufacturer: JKH Health Co., Ltd. Proprietary Name: Electronic Pulse Stimulator Model:… | 2017 |
| † | K183110 | LIVIA | 2020 |
What descends from it? (3)
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 30 years and passes through 7 companies; a new generation was cleared every 4.5 years on median.
- None of the 15 ancestors has a recall.
- Of its descendants, K232675 (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?
The FT610-B is designed for symptomatic relief and management of chronic pain, and for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities and lower extremities due to strain from exercise or normal household work activities. It is also indicated for temporary relief of pain associated with dysmenorrhea (menstrual cramps) when used with over-the-counter pain medication. In addition, it also provides a heat function intended to temporarily relieve minor aches and pains.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K211403 · printed Nov 3, 2026
Cite this page
510(k) Report. “K211403: HIVOX OTC Electrical Stimulator, FT610-B.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K211403
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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