510(k) · Cleared
Recalled · Class II · 2020Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG Accessory Kit, Charger Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stimwave Technologies Inc., Dba Stimq, LLC · GZF Stimulator, Peripheral Nerve, Implanted (Pain Relief)
Cleared on Aug 4, 2017 as substantially equivalent to K152178 (Stimq, LLC, 2016) and 1 other predicate after an 87-day review. Its family tree reaches back 6 generations to 1988. 9 later devices descend from it. It has been recalled 6 times.
- Decided
- Aug 4, 2017
- Review
- 87 days
- Class
- Class II
- Product code
- GZF
- Recalls
- 6
- Predicates
- 2
Its longest line of descent runs back 6 generations to K883780 (1988). 9 ancestors in all. 9 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK883780 Xtrel, Model Number 3425Medtronic Vascular · 1988
- 5 generations backK141399 Freedom Spinal Cord Stimulator (SCS) SystemStimwave Technologies Incorporated · 2014
- 4 generations backK150517 Freedom Spinal Cord Stimulator SystemStimwave Technologies Incorporated · 2015
- 3 generations backK160600 Freedom Spinal Cord Stimulator SystemStimwave Technologies Incorporated · 2016
- 2 generations backK162161 Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit…Stimwave Technologies Incorporated · 2016
- 1 generation backK170141 Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit…Stimwave Technologies Incorporated · 2017
- This deviceK171366 Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG…Stimwave Technologies Inc., Dba Stimq, LLC · 2017
- Descendant · cites it directly · 6 of its ownK183579 Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual 8), Nalu…Boston Scientific Neuromodulation · 2019 · Recalled
- Descendant · 2 generations on · 1 of its ownK202781 Neuspera Neurostimulation System (NNS)Neuspera Medical, Inc. · 2021
- Descendant · 2 generations on · 0 of its ownK243782 StimTrial Neuromodulation SystemBioventus, LLC · 2025
- Descendant · 2 generations on · 0 of its ownK243678 TalisMann Neuromodulation SystemBioventus, LLC · 2025
- Descendant · 2 generations on · 0 of its ownK232415 Nalu Neurostimulation System for Peripheral Nerve StimulationBoston Scientific Neuromodulation · 2024
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K183579Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual 8), Nalu Neurostimulation…Boston Scientific Neuromodulation · 2019 · cites it directly6descendants
- K202781Neuspera Neurostimulation System (NNS)Neuspera Medical, Inc. · 2021 · 2 generations on1descendant
- K243782StimTrial Neuromodulation SystemBioventus, LLC · 2025 · 2 generations on0descendants
- K243678TalisMann Neuromodulation SystemBioventus, LLC · 2025 · 2 generations on0descendants
- K232415Nalu Neurostimulation System for Peripheral Nerve StimulationBoston Scientific Neuromodulation · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K883780 | Xtrel, Model Number 3425 | Medtronic Vascular | 1988 | — |
| −5 | K141399 | Freedom Spinal Cord Stimulator (SCS) System | Stimwave Technologies Incorporated | 2014 | — |
| −4 | K150517 | Freedom Spinal Cord Stimulator System | Stimwave Technologies Incorporated | 2015 | — |
| −3 | K160600 | Freedom Spinal Cord Stimulator System | Stimwave Technologies Incorporated | 2016 | — |
| −2 | K162161 | Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable… | Stimwave Technologies Incorporated | 2016 | — |
| −1 | K170141 | Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable… | Stimwave Technologies Incorporated | 2017 | — |
| 0 (this device) | K171366 | Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG… | Stimwave Technologies Inc., Dba Stimq, LLC | 2017 | — |
| +1 | K183579 | Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual 8), Nalu… | Boston Scientific Neuromodulation | 2019 | 1 |
| +2 | K202781 | Neuspera Neurostimulation System (NNS) | Neuspera Medical, Inc. | 2021 | — |
| +2 | K243782 | StimTrial Neuromodulation System | Bioventus, LLC | 2025 | — |
| +2 | K243678 | TalisMann Neuromodulation System | Bioventus, LLC | 2025 | — |
| +2 | K232415 | Nalu Neurostimulation System for Peripheral Nerve Stimulation | Boston Scientific Neuromodulation | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2001 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 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 GZF? 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 GZF device
- #1 K243782 StimTrial Neuromodulation Systemscore 11.8 · 8 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 |
|---|---|---|---|
| * | K152178 | StimQ Peripheral Nerve Stimulator (PNS) SystemSummary page 4…GZF Device Class: Class II Classification Panel: Neurology 4. Legally Marketed Predicate Device(s) StimQ PNS System FR8A/FR4A, PDBT-915-1A (K152178) Stimwave Freedom SCS System FR8A/FR4A, PDBT-915-2A (K170141) 5. Device Description This submission builds upon the existing St… | 2016 |
| * | K170141 | Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly…Summary page 4…n Panel: Neurology 4. Legally Marketed Predicate Device(s) StimQ PNS System FR8A/FR4A, PDBT-915-1A (K152178) Stimwave Freedom SCS System FR8A/FR4A, PDBT-915-2A (K170141) 5. Device Description This submission builds upon the existing StimQ product family by incorporating identical products from o… | 2017 |
| † | K141399 | Freedom Spinal Cord Stimulator (SCS) System | 2014 |
| † | K150517 | Freedom Spinal Cord Stimulator System | 2015 |
| † | K160600 | Freedom Spinal Cord Stimulator System | 2016 |
| † | K162161 | Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly… | 2016 |
What descends from it? (9)
3 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 15, 2020 | Class II | Z-2929-2020 | Under Investigation by firm | The product contains a non-functional component not referenced in product labeling. |
| Jul 15, 2020 | Class II | Z-2930-2020 | Under Investigation by firm | The product contains a non-functional component not referenced in product labeling. |
| Jul 15, 2020 | Class II | Z-2933-2020 | Under Investigation by firm | The product contains a non-functional component not referenced in product labeling. |
| Jul 15, 2020 | Class II | Z-2931-2020 | Under Investigation by firm | The product contains a non-functional component not referenced in product labeling. |
| Jul 15, 2020 | Class II | Z-2932-2020 | Under Investigation by firm | The product contains a non-functional component not referenced in product labeling. |
| Jul 15, 2020 | Class II | Z-2928-2020 | Under Investigation by firm | The product contains a non-functional component not referenced in product labeling. |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 years and passes through 3 companies; a new generation was cleared every 8 months on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K183579 (Boston Scientific Neuromodulation, 2019) has gone furthest, with 6 descendants of its own.
How does its category compare?
All GZF devicesGZF Stimulator, Peripheral Nerve, Implanted (Pain Relief): FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · GZF
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GZF
99in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GZF
No recall names GZF since 2007.
Adverse event reports per year · GZF
597in 2025
MAUDE reports naming product code GZF, 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 | 0 | — | 0 | 7 |
| 2008 | 0 | — | 0 | 13 |
| 2009 | 0 | — | 0 | 10 |
| 2010 | 0 | — | 0 | 24 |
| 2011 | 0 | — | 0 | 17 |
| 2012 | 0 | — | 0 | 12 |
| 2013 | 0 | — | 0 | 77 |
| 2014 | 0 | — | 0 | 268 |
| 2015 | 1 | — | 0 | 346 |
| 2016 | 1 | — | 0 | 414 |
| 2017 | 1 | — | 0 | 330 |
| 2018 | 0 | — | 0 | 318 |
| 2019 | 3 | 99 | 0 | 64 |
| 2020 | 2 | — | 0 | 104 |
| 2021 | 1 | — | 0 | 226 |
| 2022 | 1 | — | 0 | 183 |
| 2023 | 1 | — | 0 | 524 |
| 2024 | 2 | — | 0 | 678 |
| 2025 | 2 | — | 0 | 597 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The StimQ Peripheral Nerve Stimulator (PNS) System is indicated for pain management
in adults who have severe intractable chronic pain of peripheral nerve origin, as the sole
mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary
approach. The StimQ PNS System is not intended to treat pain in the craniofacial region.
The StimQ Trial Lead Kit is only used in conjunction with the StimQ Stimulator
Receiver Kit. The trial devices are solely used for trial stimulation (no longer than 30
days) to determine efficacy before recommendation for a permanent (long term) device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171366 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171366: Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG Accessory Kit, Charger Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171366
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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