510(k) · Cleared
ClearedNu-beca Transcutaneous Electrical Nerve Stimulation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nu-Beca & Maxcellent Co. · NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
Cleared on Jul 19, 2023 as substantially equivalent to K211403 (Hivox Biotek, Inc., 2021) after a 287-day review. Its family tree reaches back 7 generations to 1991.
- Decided
- Jul 19, 2023
- Review
- 287 days
- Class
- Class II
- Product code
- NUH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K912178 (1991). 16 ancestors in all, the oldest K880042 (1988). No later device cites it as a predicate yet.
- Root · 7 generations backK912178 Bio Tens 601, 606 and 608 (3000)Skylark Device Co., Ltd. · 1991
- 6 generations backK972244 NT2000Bio-Medical Research, Ltd. · 1998
- 5 generations backK990787 TRIO 300Ito Co., Ltd. · 1999
- 4 generations backK023231 Elfcare Device, Models 314A Through 314GMediseb, Ltd. · 2003
- 3 generations backK070299 Ezfit Digital Heating Tens (Model NO.: HR-661/UC-101)Ezfit Technology, Inc. · 2007
- 2 generations backK162517 Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13Jkh Health Co., Ltd. · 2017
- 1 generation backK211403 HIVOX OTC Electrical Stimulator, FT610-BHivox Biotek, Inc. · 2021
- This deviceK223151 Nu-beca Transcutaneous Electrical Nerve StimulationNu-Beca & Maxcellent Co. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K912178 | Bio Tens 601, 606 and 608 (3000) | Skylark Device Co., Ltd. | 1991 | — |
| −6 | K972244 | NT2000 | Bio-Medical Research, Ltd. | 1998 | — |
| −5 | K990787 | TRIO 300 | Ito Co., Ltd. | 1999 | — |
| −4 | K023231 | Elfcare Device, Models 314A Through 314G | Mediseb, Ltd. | 2003 | — |
| −3 | K070299 | Ezfit Digital Heating Tens (Model NO.: HR-661/UC-101) | Ezfit Technology, Inc. | 2007 | — |
| −2 | K162517 | Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13 | Jkh Health Co., Ltd. | 2017 | — |
| −1 | K211403 | HIVOX OTC Electrical Stimulator, FT610-B | Hivox Biotek, Inc. | 2021 | — |
| 0 (this device) | K223151 | Nu-beca Transcutaneous Electrical Nerve Stimulation | Nu-Beca & Maxcellent Co. | 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 |
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 |
|---|---|---|---|
| * | K211403 | HIVOX OTC Electrical Stimulator, FT610-BSummary page 4…X OTC Electrical Stimulator Mode Name FT610-B Manufacturer HIVOX BIOTEK INC. Product Code NUH 510(k) Number K211403 Review Panel Neurology Classification 2 Regulation Number 21 CFR §882.5890… | 2021 |
| † | K160052 | CUR Model 1 | 2016 |
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 32 years and passes through 8 companies; a new generation was cleared every 4.3 years on median.
- None of the 16 ancestors has a recall.
- 2 other devices also cite its predicate K211403.
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. 2023, 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 nu-beca Transcutaneous Electrical Nerve Stimulation is indicated for temporary relief of pain associated with sore and aching muscles in the lower back and upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223151 · printed Nov 3, 2026
Cite this page
510(k) Report. “K223151: Nu-beca Transcutaneous Electrical Nerve Stimulation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K223151
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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