510(k) · Cleared
ClearedNeurodyn Portable Tens Nfes, Neurodyn Portable Tens
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Techlink International · GZI Stimulator, Neuromuscular, External Functional
Cleared on Jul 3, 2014 as substantially equivalent to K121369 (Ibramed Equipamentos Medicos, 2012) and 1 other predicate after a 372-day review. Its family tree reaches back 2 generations to 1993.
- Decided
- Jul 3, 2014
- Review
- 372 days
- Class
- Class II
- Product code
- GZI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K931781 (1993). 6 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K931781 | Jace Tri-Stim Device | Jace Systems, Inc. | 1993 | — |
| −1 | K021100 | 300 PV Complete Electrotherapy System | Empi | 2002 | — |
| 0 (this device) | K131923 | Neurodyn Portable Tens Nfes, Neurodyn Portable Tens | Techlink International | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
| 2012 | 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 GZI? 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 GZI device
- #1 K243828 Cionic Neural Sleeve (NS-200)score 12.9 · 13 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 |
|---|---|---|---|
| * | K121369 | Neurodyn Ruby Muscle Stimulator, Neurodyn Aussie Muscle StimulatorSummary page 1…GZJ; GZI Classification Panel: Neurology Regulation Numbers: 21 CFR 882.5890 and 21 CFR 882.5810 Substantial Equivalence: K121369 Neurodyn/Aussie Powered Muscle Stimnulator by Ibramed; K021100 300 PV… | 2012 |
| * | K021100 | 300 PV Complete Electrotherapy SystemSummary page 1…21 CFR 882.5890 and 21 CFR 882.5810 Substantial Equivalence: K121369 Neurodyn/Aussie Powered Muscle Stimnulator by Ibramed; K021100 300 PV Complete Electrotherapy System by EMPI Indications for Use Indications for FES device: -… | 2002 |
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 21 years and passes through 3 companies; a new generation was cleared every 12.0 years on median.
- 1 of the 6 ancestors has a recall of any class.
- 2 other devices also cite its predicate K121369.
How does its category compare?
All GZI devicesGZI Stimulator, Neuromuscular, External Functional: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · GZI
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GZI
110in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GZI
1in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GZI
3in 2025
MAUDE reports naming product code GZI, 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 | 81 | 0 | 1 |
| 2008 | 1 | — | 1 | 2 |
| 2009 | 1 | — | 0 | 8 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 6 | 139 | 0 | 3 |
| 2012 | 2 | — | 0 | 2 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 3 | 299 | 0 | 2 |
| 2015 | 1 | — | 0 | 3 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 6 | 168 | 0 | 2 |
| 2018 | 2 | — | 0 | 1 |
| 2019 | 2 | — | 0 | 4 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 1 |
| 2022 | 4 | 110 | 0 | 3 |
| 2023 | 1 | — | 0 | 1 |
| 2024 | 2 | — | 0 | 1 |
| 2025 | 2 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
indications for FES device:
- Stimulation of the muscles in the leg and ankle of partially paralyzed patients to provide flexion of the foot and thus improve the patients gait.
Indications for TENS device:
- Symptomatic relief of chronic (long term) intractable pain
- Symptomatic relief of past-traumatic acute pain and post surgical pain
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131923 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131923: Neurodyn Portable Tens Nfes, Neurodyn Portable Tens.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131923
Report an extraction error
Are you the manufacturer?
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