510(k) · Cleared
ClearedSensus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neurometrix, Inc. · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Cleared on Jul 2, 2013 as substantially equivalent to K121184 (Neurometrix, Inc., 2012) after a 90-day review. Its family tree reaches back 5 generations to 1988. 13 later devices descend from it.
- Decided
- Jul 2, 2013
- Review
- 90 days
- Class
- Class II
- Product code
- GZJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K881114 (1988). 7 ancestors in all. 13 later devices descend from it, 2 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 backK090922 Empi Active Transcutaneous Nerve StimulatorEmpi · 2009
- 1 generation backK121184 SensusNeurometrix, Inc. · 2012
- This deviceK130919 SensusNeurometrix, Inc. · 2013
- Descendant · cites it directly · 11 of its ownK140333 AscendNeurometrix, Inc. · 2014
- Descendant · 2 generations on · 7 of its ownK182203 JKH Stimulator PlusJkh USA, LLC · 2019
- Descendant · 3 generations on · 4 of its ownK191151 JKH Stimulator PlusJkh USA, LLC · 2019
- Descendant · 4 generations on · 1 of its ownK231569 ManaFlexx 2 (model: MF002-RX, MF002-OTC)Manamed, Inc. · 2023
- Descendant · 3 generations on · 1 of its ownK202159 actiTENSSublimed · 2020
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K140333AscendNeurometrix, Inc. · 2014 · cites it directly11descendants
- K182203JKH Stimulator PlusJkh USA, LLC · 2019 · 2 generations on7descendants
- K191151JKH Stimulator PlusJkh USA, LLC · 2019 · 3 generations on4descendants
- K231569ManaFlexx 2 (model: MF002-RX, MF002-OTC)Manamed, Inc. · 2023 · 4 generations on1descendant
- K202159actiTENSSublimed · 2020 · 3 generations on1descendant
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 | K090922 | Empi Active Transcutaneous Nerve Stimulator | Empi | 2009 | — |
| −1 | K121184 | Sensus | Neurometrix, Inc. | 2012 | — |
| 0 (this device) | K130919 | Sensus | Neurometrix, Inc. | 2013 | — |
| +1 | K140333 | Ascend | Neurometrix, Inc. | 2014 | — |
| +2 | K182203 | JKH Stimulator Plus | Jkh USA, LLC | 2019 | — |
| +3 | K191151 | JKH Stimulator Plus | Jkh USA, LLC | 2019 | — |
| +4 | K231569 | ManaFlexx 2 (model: MF002-RX, MF002-OTC) | Manamed, Inc. | 2023 | — |
| +3 | K202159 | actiTENS | Sublimed | 2020 | — |
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 |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 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 GZJ? 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 GZJ device
- #1 K252767 actiTENS miniscore 13.1 · 9 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 |
|---|---|---|---|
| * | K121184 | SensusSummary page 1…ator, TENS Classification Name: 882.5890 OZJ Transcutaneous electrical nerve stimulator for pain relief PREDICATE DEVICE NeuroMetrix SENSUS (K 121184) INTENDED USE The NeuroMetrix SENSUS is intended for use as a transcutaneous electric nerve stimulation device for the symptom… | 2012 |
| † | K121816 | Sensus Electrode | 2012 |
| † | K121059 | Soleoline, Soleo Stim, Soleo Sono, Soleo Sonostim | 2012 |
| † | K121305 | Sterling Medical Impulse 3 Stimulator | 2012 |
| † | K080950 | Stiwell MED4 | 2009 |
What descends from it? (13)
See all 132 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 2 companies; a new generation was cleared every 3.2 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K140333 (Neurometrix, Inc., 2014) has gone furthest, with 11 descendants of its own.
How does its category compare?
All GZJ devicesGZJ Stimulator, Nerve, Transcutaneous, For Pain Relief: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · GZJ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GZJ
207in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GZJ
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GZJ
13in 2025
MAUDE reports naming product code GZJ, 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 | 13 | 223 | 4 | 4 |
| 2008 | 11 | 136 | 1 | 45 |
| 2009 | 16 | 155 | 0 | 17 |
| 2010 | 5 | 232 | 0 | 22 |
| 2011 | 5 | 168 | 1 | 22 |
| 2012 | 12 | 154 | 0 | 20 |
| 2013 | 2 | — | 0 | 10 |
| 2014 | 4 | 344 | 0 | 23 |
| 2015 | 3 | 202 | 0 | 18 |
| 2016 | 3 | 163 | 0 | 32 |
| 2017 | 3 | 113 | 0 | 58 |
| 2018 | 2 | — | 0 | 21 |
| 2019 | 3 | 156 | 0 | 7 |
| 2020 | 4 | 183 | 0 | 10 |
| 2021 | 3 | 231 | 0 | 5 |
| 2022 | 4 | 175 | 0 | 4 |
| 2023 | 1 | — | 0 | 39 |
| 2024 | 3 | 207 | 0 | 12 |
| 2025 | 1 | — | 0 | 13 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The NeuroMetrix SENSUS is intended for use as a transcutaneous electric 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 the
NeuroMetrix SENSUS Electrode.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130919 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130919: Sensus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130919
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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