510(k) · Cleared
ClearedSynapse Transcutaneous Electrical Stimulation Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synapse Electroceutical Limited · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Cleared on May 27, 2015 as substantially equivalent to K130919 (Neurometrix, Inc., 2013) after a 202-day review. Its family tree reaches back 6 generations to 1988.
- Decided
- May 27, 2015
- Review
- 202 days
- Class
- Class II
- Product code
- GZJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K881114 (1988). 8 ancestors in all. No later device cites it as a predicate yet.
- 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 deviceK143198 Synapse Transcutaneous Electrical Stimulation DeviceSynapse Electroceutical Limited · 2015
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) | K143198 | Synapse Transcutaneous Electrical Stimulation Device | Synapse Electroceutical Limited | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 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 |
|---|---|---|---|
| * | K130919 | SensusSummary page 4…ification Name Transcutaneous Electrical Nerve Stimulator for Pain Relief (21 CFR 882.5890, Product Code GZJ) PREDICATE DEVICE NeuroMetrix SENSUS™ (K130919) DEVICE DESCRIPTION The function of the Synapse Transcutaneous Electrical Stimulation Device is to apply a series of pre-progra… | 2013 |
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 27 years and passes through 3 companies; a new generation was cleared every 3.2 years on median.
- None of the 8 ancestors has a recall.
- 1 other device also cites its predicate K130919.
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. 2015, 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 Synapse Transcutaneous Electrical Stimulation Device is intended for use for the symptomatic relief and management of chronic intractable pain. The Synapse Transcutaneous Electrical Stimulation Device may be used during sleep.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143198 · printed Nov 5, 2026
Cite this page
510(k) Report. “K143198: Synapse Transcutaneous Electrical Stimulation Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K143198
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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