510(k) · Cleared
ClearedAscend
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neurometrix, Inc. · NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
Cleared on Jul 3, 2014 as substantially equivalent to K130919 (Neurometrix, Inc., 2013) after a 143-day review. Its family tree reaches back 6 generations to 1988. 11 later devices descend from it.
- Decided
- Jul 3, 2014
- Review
- 143 days
- Class
- Class II
- Product code
- NUH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K881114 (1988). 8 ancestors in all. 11 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK881114 Empi Model 989, TensEmpi · 1988
- 5 generations backK970203 Epix VTEmpi · 1997
- 4 generations backK061650 Select Tens, Model 4600SEmpi · 2007
- 3 generations backK090922 Empi Active Transcutaneous Nerve StimulatorEmpi · 2009
- 2 generations backK121184 SensusNeurometrix, Inc. · 2012
- 1 generation backK130919 SensusNeurometrix, Inc. · 2013
- This deviceK140333 AscendNeurometrix, Inc. · 2014
- Descendant · cites it directly · 7 of its ownK182203 JKH Stimulator PlusJkh USA, LLC · 2019
- Descendant · 2 generations on · 4 of its ownK191151 JKH Stimulator PlusJkh USA, LLC · 2019
- Descendant · 3 generations on · 1 of its ownK231569 ManaFlexx 2 (model: MF002-RX, MF002-OTC)Manamed, Inc. · 2023
- Descendant · 2 generations on · 1 of its ownK202159 actiTENSSublimed · 2020
- Descendant · cites it directly · 1 of its ownK160052 CUR Model 1Thimble Bioelectronics, Inc. · 2016
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K182203JKH Stimulator PlusJkh USA, LLC · 2019 · cites it directly7descendants
- K191151JKH Stimulator PlusJkh USA, LLC · 2019 · 2 generations on4descendants
- K231569ManaFlexx 2 (model: MF002-RX, MF002-OTC)Manamed, Inc. · 2023 · 3 generations on1descendant
- K202159actiTENSSublimed · 2020 · 2 generations on1descendant
- K160052CUR Model 1Thimble Bioelectronics, Inc. · 2016 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K881114 | Empi Model 989, Tens | Empi | 1988 | — |
| −5 | K970203 | Epix VT | Empi | 1997 | — |
| −4 | K061650 | Select Tens, Model 4600S | Empi | 2007 | — |
| −3 | K090922 | Empi Active Transcutaneous Nerve Stimulator | Empi | 2009 | — |
| −2 | K121184 | Sensus | Neurometrix, Inc. | 2012 | — |
| −1 | K130919 | Sensus | Neurometrix, Inc. | 2013 | — |
| 0 (this device) | K140333 | Ascend | Neurometrix, Inc. | 2014 | — |
| +1 | K182203 | JKH Stimulator Plus | Jkh USA, LLC | 2019 | — |
| +2 | K191151 | JKH Stimulator Plus | Jkh USA, LLC | 2019 | — |
| +3 | K231569 | ManaFlexx 2 (model: MF002-RX, MF002-OTC) | Manamed, Inc. | 2023 | — |
| +2 | K202159 | actiTENS | Sublimed | 2020 | — |
| +1 | K160052 | CUR Model 1 | Thimble Bioelectronics, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K130919 | SensusSummary page 2…arging, and error conditions. COMPARISON TO PREDICATES ASCEND has similar indications for use and identical technological characteristics as the cleared SENSUS device (K130919). The only substantive difference is that ASCEND is labeled for over-the- counter use while SENSUS is labeled for prescription us… | 2013 |
| Kept off the family tree | K130037 | FDA’s K130037 is Breathe Cpap System Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2013 |
What descends from it? (11)
See all 113 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 26 years and passes through 2 companies; a new generation was cleared every 3.2 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K182203 (Jkh USA, LLC, 2019) has gone furthest, with 7 descendants of its own.
- 1 other device also cites its predicate K130919.
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. 2014, 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?
ASCEND is intended for use as a transcutaneous electrical nerve stimulation device for temporary relief of pain associated with sore and aching muscles in the lower extremities due to strain from exercise or normal household and work activities.
ASCEND is intended for use as a transcutaneous electrical nerve stimulation device for the symptomatic relief and management of chronic intractable pain.
The device may be used during sleep. The device is labeled for use only with compatible NeuroMetrix electrodes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140333 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140333: Ascend.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140333
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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