510(k) · Cleared
ClearedFreedom Spinal Cord Stimulator System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stimwave Technologies Incorporated · GZB Stimulator, Spinal-Cord, Implanted (Pain Relief)
Cleared on Aug 26, 2016 as substantially equivalent to K150517 (Stimwave Technologies Incorporated, 2015) and 1 other predicate after a 177-day review. Its family tree reaches back 3 generations to 1988. 21 later devices descend from it.
- Decided
- Aug 26, 2016
- Review
- 177 days
- Class
- Class II
- Product code
- GZB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K883780 (1988). 5 ancestors in all. 21 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK883780 Xtrel, Model Number 3425Medtronic Vascular · 1988
- 2 generations backK141399 Freedom Spinal Cord Stimulator (SCS) SystemStimwave Technologies Incorporated · 2014
- 1 generation backK150517 Freedom Spinal Cord Stimulator SystemStimwave Technologies Incorporated · 2015
- This deviceK160600 Freedom Spinal Cord Stimulator SystemStimwave Technologies Incorporated · 2016
- Descendant · cites it directly · 20 of its ownK162161 Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit…Stimwave Technologies Incorporated · 2016
- Descendant · 2 generations on · 19 of its ownK170141 Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit…Stimwave Technologies Incorporated · 2017
- Descendant · 3 generations on · 9 of its ownK171366 Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG…Stimwave Technologies Inc., Dba Stimq, LLC · 2017 · Recalled
- Descendant · 4 generations on · 6 of its ownK183579 Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual 8), Nalu…Boston Scientific Neuromodulation · 2019 · Recalled
- Descendant · 3 generations on · 6 of its ownK183047 Nalu Neurostimulation SystemBoston Scientific Neuromodulation · 2019 · Recalled
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K162161Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly…Stimwave Technologies Incorporated · 2016 · cites it directly20descendants
- K170141Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly…Stimwave Technologies Incorporated · 2017 · 2 generations on19descendants
- K171366Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG Accessory…Stimwave Technologies Inc., Dba Stimq, LLC · 2017 · 3 generations on9descendants
- K183579Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual 8), Nalu Neurostimulation…Boston Scientific Neuromodulation · 2019 · 4 generations on6descendants
- K183047Nalu Neurostimulation SystemBoston Scientific Neuromodulation · 2019 · 3 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K883780 | Xtrel, Model Number 3425 | Medtronic Vascular | 1988 | — |
| −2 | K141399 | Freedom Spinal Cord Stimulator (SCS) System | Stimwave Technologies Incorporated | 2014 | — |
| −1 | K150517 | Freedom Spinal Cord Stimulator System | Stimwave Technologies Incorporated | 2015 | — |
| 0 (this device) | K160600 | Freedom Spinal Cord Stimulator System | Stimwave Technologies Incorporated | 2016 | — |
| +1 | K162161 | Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable… | Stimwave Technologies Incorporated | 2016 | — |
| +2 | K170141 | Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable… | Stimwave Technologies Incorporated | 2017 | — |
| +3 | K171366 | Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG… | Stimwave Technologies Inc., Dba Stimq, LLC | 2017 | 6 |
| +4 | K183579 | Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual 8), Nalu… | Boston Scientific Neuromodulation | 2019 | 1 |
| +3 | K183047 | Nalu Neurostimulation System | Boston Scientific Neuromodulation | 2019 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 5 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 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 GZB? 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 GZB device
- #1 K221376 Nalu Neurostimulation Systemscore 8.9 · 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? (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 |
|---|---|---|---|
| * | K150517 | Freedom Spinal Cord Stimulator SystemSummary page 4…ice Class: Class II Classification Panel: Neurology 4. Legally Marketed Predicate Device(s) Stimwave Freedom SCS System FR8A/FR4A, LBRD-915-2A (K150517) Stimwave Freedom SCS System FRE4-A001, FRT4-A001, WAA-A012 (K141399) 5. Device Description The Stimwave Technologies Incorpora… | 2015 |
| * | K141399 | Freedom Spinal Cord Stimulator (SCS) SystemSummary page 4…rology 4. Legally Marketed Predicate Device(s) Stimwave Freedom SCS System FR8A/FR4A, LBRD-915-2A (K150517) Stimwave Freedom SCS System FRE4-A001, FRT4-A001, WAA-A012 (K141399) 5. Device Description The Stimwave Technologies Incorporated (Stimwave) Freedom Spinal Cord SCS System (System) is used for sp… | 2014 |
What descends from it? (21)
See all 211 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162161 | Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly… | 2016 | 20 |
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 28 years and passes through 2 companies; a new generation was cleared every 1.2 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K162161 (Stimwave Technologies Incorporated, 2016) has gone furthest, with 20 descendants of its own.
- 2 other devices also cite its predicate K150517.
How does its category compare?
All GZB devicesGZB Stimulator, Spinal-Cord, Implanted (Pain Relief): FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · GZB
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · GZB
149in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GZB
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GZB
313in 2025
MAUDE reports naming product code GZB, 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 | 2 | — | 0 | 201 |
| 2008 | 1 | — | 1 | 68 |
| 2009 | 3 | 62 | 0 | 59 |
| 2010 | 1 | — | 1 | 157 |
| 2011 | 4 | 67 | 0 | 471 |
| 2012 | 2 | — | 0 | 1,090 |
| 2013 | 2 | — | 0 | 4,428 |
| 2014 | 2 | — | 0 | 10,849 |
| 2015 | 2 | — | 0 | 7,507 |
| 2016 | 2 | — | 0 | 4,556 |
| 2017 | 2 | — | 0 | 5,511 |
| 2018 | 1 | — | 0 | 5,244 |
| 2019 | 4 | 149 | 0 | 643 |
| 2020 | 2 | — | 0 | 466 |
| 2021 | 1 | — | 0 | 332 |
| 2022 | 1 | — | 0 | 209 |
| 2023 | 0 | — | 0 | 236 |
| 2024 | 1 | — | 0 | 318 |
| 2025 | 0 | — | 0 | 313 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The Freedom Spinal Cord Stimulator (SCS) System is intended as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach for chronic, intractable pain of the trunk and/or lower limbs, including unilateral or bilateral pain. The Freedom-8A Trial Lead Kit is only used in conjunction with the Freedom-8A Stimulator Receiver Kit, and the Freedom-4A Trial Lead Kit is used for either the Receiver Kit Freedom-4A Stimulator or the Receiver Kit Freedom-8A Stimulator. 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/K160600 · printed Nov 4, 2026
Cite this page
510(k) Report. “K160600: Freedom Spinal Cord Stimulator System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160600
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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