510(k) · Cleared
ClearedTranscutaneous Electrical Nerve Stimulators (TENS)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Andon Health Co, Ltd. · NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
Cleared on Aug 14, 2015 as substantially equivalent to K131159 (Chattem, Inc., 2013) and 1 other predicate after a 217-day review. Its family tree reaches back 5 generations to 1988. 1 later device descends from it.
- Decided
- Aug 14, 2015
- Review
- 217 days
- Class
- Class II
- Product code
- NUH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K881114 (1988). 16 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK881114 Empi Model 989, TensEmpi · 1988
- 4 generations backK970203 Epix VTEmpi · 1997
- 3 generations backK061650 Select Tens, Model 4600SEmpi · 2007
- 2 generations backK113037 Pain-AidPdi Works, LLC · 2012
- 1 generation backK131159 SmartreliefChattem, Inc. · 2013
- This deviceK150043 Transcutaneous Electrical Nerve Stimulators (TENS)Andon Health Co, Ltd. · 2015
- Descendant · cites it directly · 0 of its ownK222867 AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS)Andon Health Co, Ltd. · 2022
Most influential descendants
Showing 1 of 1 · See all- K222867AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS)Andon Health Co, Ltd. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K881114 | Empi Model 989, Tens | Empi | 1988 | — |
| −4 | K970203 | Epix VT | Empi | 1997 | — |
| −3 | K061650 | Select Tens, Model 4600S | Empi | 2007 | — |
| −2 | K113037 | Pain-Aid | Pdi Works, LLC | 2012 | — |
| −1 | K131159 | Smartrelief | Chattem, Inc. | 2013 | — |
| 0 (this device) | K150043 | Transcutaneous Electrical Nerve Stimulators (TENS) | Andon Health Co, Ltd. | 2015 | — |
| +1 | K222867 | AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS) | Andon Health Co, Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 |
|---|---|---|---|
| * | K131159 | SmartreliefSummary page 4…Neurology 4.0 Predicate device information Information Predicate 1 Predicate 2 510(k) number: K131159 K140168 Manufacturer Chattem, Inc. EasyMed Instruments… | 2013 |
| * | K140168 | Easystim TN28_OtcSummary page 4…gy 4.0 Predicate device information Information Predicate 1 Predicate 2 510(k) number: K131159 K140168 Manufacturer Chattem, Inc. EasyMed Instruments… | 2014 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K222867 | AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS) | 2022 | 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 27 years and passes through 4 companies; a new generation was cleared every 5.1 years on median.
- None of the 16 ancestors has a recall.
- Of its descendants, K222867 (Andon Health Co, Ltd., 2022) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K131159.
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. 2015, 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 AD-2129A TENS device is intended for temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities. It is also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150043 · printed Nov 5, 2026
Cite this page
510(k) Report. “K150043: Transcutaneous Electrical Nerve Stimulators (TENS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K150043
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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