510(k) Report

510(k) · Cleared

Cleared

Freedom Spinal Cord Stimulator (SCS) System

K141399510(k) TraditionalCleared Oct 10, 2014135-day reviewClass II21 CFR 882.5880

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Stimwave Technologies Incorporated · GZB Stimulator, Spinal-Cord, Implanted (Pain Relief)

Cleared on Oct 10, 2014 as substantially equivalent to K934065 (Medtronic Vascular, 1995) and 2 other predicates after a 135-day review. Its family tree reaches back 1 generation to 1988. 24 later devices descend from it.

Decided
Oct 10, 2014
Review
135 days
Class
Class II
Product code
GZB
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K883780 (1988). 3 ancestors in all. 24 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor1995: 1 other ancestor2016: 3 descendants cleared2015: 1 descendant cleared2020: 3 descendants cleared2017: 2 descendants cleared2019: 5 descendants cleared2018: 1 descendant cleared2024: 3 descendants cleared2025: 2 descendants cleared2021: 2 descendants cleared2023: 1 descendant cleared2022: 1 descendant clearedK883780 · Xtrel, Model Number 3425 · Medtronic Vascular · 19881990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 5 descendants2 generations forward: 2 descendants3 generations forward: 4 descendants4 generations forward: 9 descendants5 generations forward: 2 descendants6 generations forward: 1 descendant7 generations forward: 1 descendant K883780 · Xtrel, Model Number 3425 · Medtronic Vascular · 19880+5
  1. Root · 1 generation backK883780 Xtrel, Model Number 3425Medtronic Vascular · 1988
  2. This deviceK141399 Freedom Spinal Cord Stimulator (SCS) SystemStimwave Technologies Incorporated · 2014
  3. Descendant · cites it directly · 23 of its ownK150517 Freedom Spinal Cord Stimulator SystemStimwave Technologies Incorporated · 2015
  4. Descendant · cites it directly · 21 of its ownK160600 Freedom Spinal Cord Stimulator SystemStimwave Technologies Incorporated · 2016
  5. Descendant · cites it directly · 20 of its ownK162161 Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit…Stimwave Technologies Incorporated · 2016
  6. Descendant · 2 generations on · 19 of its ownK170141 Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit…Stimwave Technologies Incorporated · 2017
  7. Descendant · cites it directly · 10 of its ownK152178 StimQ Peripheral Nerve Stimulator (PNS) SystemStimq, LLC · 2016 · Recalled

Showing 5 of 24 descendants. See all descendants

Descendants cleared per year

2015: 12016: 32017: 22018: 12019: 52020: 32021: 22022: 12023: 12024: 32025: 2
2015high 5 (2019) · low 0 (2026)2026

Most influential descendants

Showing 5 of 24 · See all
  • K150517Freedom Spinal Cord Stimulator SystemStimwave Technologies Incorporated · 2015 · cites it directly23descendants
  • K160600Freedom Spinal Cord Stimulator SystemStimwave Technologies Incorporated · 2016 · cites it directly21descendants
  • 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
  • K152178StimQ Peripheral Nerve Stimulator (PNS) SystemStimq, LLC · 2016 · cites it directly10descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K883780Xtrel, Model Number 3425Medtronic Vascular1988—
0 (this device)K141399Freedom Spinal Cord Stimulator (SCS) SystemStimwave Technologies Incorporated2014—
+1K150517Freedom Spinal Cord Stimulator SystemStimwave Technologies Incorporated2015—
+1K160600Freedom Spinal Cord Stimulator SystemStimwave Technologies Incorporated2016—
+1K162161Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable…Stimwave Technologies Incorporated2016—
+2K170141Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable…Stimwave Technologies Incorporated2017—
+1K152178StimQ Peripheral Nerve Stimulator (PNS) SystemStimq, LLC20166

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
201630
201720
201810
201950
202030
202120
202210
202310
202430
202520
FIG. 1 — Lineage of K141399, 1988–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K221376 Nalu Neurostimulation Systemscore 8.9 · 9 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (3)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K934065Medtronic Mattrix 3271/3272 Neurostimulation System
Summary page 4
…e Class: Class II Classification Panel: Neurology 4. Legally Marketed Predicate Device(s) Medtronic Mattrix 3271/3272 Neuromodulation System (K934065) Medtronic Xtrel, Model Number 3425 Receiver (K883780) ANS Renew Neurostimulation System Transmitter, Model 2508, Receiver Model…
Medtronic Vascular1995—
*K883780Xtrel, Model Number 3425
Summary page 4
…l: Neurology 4. Legally Marketed Predicate Device(s) Medtronic Mattrix 3271/3272 Neuromodulation System (K934065) Medtronic Xtrel, Model Number 3425 Receiver (K883780) ANS Renew Neurostimulation System Transmitter, Model 2508, Receiver Model 3408, Antennae Models 1220 and 1230, Lead Models 3143,…
Medtronic Vascular1988—
*K000852Renew Neurostimulation System
Summary page 4
…ter, Model 2508, Receiver Model 3408, Antennae Models 1220 and 1230, Lead Models 3143, 3146, 3153, 3156, 3183 and 3186, Extension Models 3382, 3383, 3341, 3342 and 3343 (K000852) 5. Device Description The Stimwave Technologies Incorporated (Stimwave) Freedom Spinal Cord SCS System (System) is used for sp…
Advanced Neuromodulation Systems2001—

Also cleared against K934065: 4 other devices →

What descends from it? (24)

See all 24

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K150517Freedom Spinal Cord Stimulator SystemStimwave Technologies Incorporated201523
K160600Freedom Spinal Cord Stimulator SystemStimwave Technologies Incorporated201621
K162161Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly…Stimwave Technologies Incorporated201620
K152178StimQ Peripheral Nerve Stimulator (PNS) SystemStimq, LLC201610
K200848Stimulator, Stimulator Kit, External Transmitter, External Transmitter KitMicron Medical Corporation20200

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?

  • None of the 3 ancestors has a recall.
  • Of its descendants, K150517 (Stimwave Technologies Incorporated, 2015) has gone furthest, with 23 descendants of its own.
  • 4 other devices also cite its predicate K934065.

How does its category compare?

All GZB devices

GZB Stimulator, Spinal-Cord, Implanted (Pain Relief): FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

FDA decisions per year · GZB

1in 2024

2007: 22008: 12009: 32010: 12011: 42012: 22013: 22014: 22015: 22016: 22017: 22018: 12019: 42020: 22021: 12022: 12024: 1
2007high 4 (2011) · low 0 (2023)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GZB

149in 2019

2009: 62 days median2011: 67 days median2019: 149 days median
2007high 149 (2019) · low 62 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GZB

1in 2010

2008: 12010: 12026 (partial year): 1
2007high 1 (2008) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GZB

313in 2025

2007: 2012008: 682009: 592010: 1572011: 4712012: 1,0902013: 4,4282014: 10,8492015: 7,5072016: 4,5562017: 5,5112018: 5,2442019: 6432020: 4662021: 3322022: 2092023: 2362024: 3182025: 313
2007high 10,849 (2014) · low 59 (2009)2025

MAUDE reports naming product code GZB, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—0201
20081—168
2009362059
20101—1157
20114670471
20122—01,090
20132—04,428
20142—010,849
20152—07,507
20162—04,556
20172—05,511
20181—05,244
201941490643
20202—0466
20211—0332
20221—0209
20230—0236
20241—0318
20250—0313
20260—1—

What is it indicated for?

The Stimwave Technologies Incorporated 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 FRT4-A001 device is solely used for trial stimulation (no longer than 30 days) of the permanent FRE4-A001 device.

Indications for use as stated in the FDA summary.

Also cleared against K934065

4 other devices cite the same predicate.

  • K152178StimQ Peripheral Nerve Stimulator (PNS) SystemStimq, LLC · 20166 recalls
  • K150517Freedom Spinal Cord Stimulator SystemStimwave Technologies Incorporated · 2015
  • K040568Polyether Urethane Material Change in Neurostimulation LeadsMedtronic Vascular · 2004
  • K972043Medtronic Model 3273/3274 RF Receiver and Model 3629/3630 ScreenerMedtronic Vascular · 1997

More from Stimwave Technologies Incorporated

8 FDA decisions under this applicant name. See the company

  • K182720Freedom Spinal Cord Stimulator (SCS) SystemStimwave Technologies Incorporated · 2019
  • K180981Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly KitStimwave Technologies Incorporated · 2018
  • K172644Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, Loading BaseStimwave Technologies Incorporated · 2017
  • K170141Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger KitStimwave Technologies Incorporated · 2017
  • K162161Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger KitStimwave Technologies Incorporated · 2016

Recent decisions in GZB

The GZB category page

  • K233801Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve…Boston Scientific Neuromodulation · 20241 recall
  • K221376Nalu Neurostimulation SystemBoston Scientific Neuromodulation · 2022
  • K203547Nalu Neurostimulation SystemBoston Scientific Neuromodulation · 2021
  • K202274Nalu Neurostimulation Kit (lnte:gmted 40 em: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 em…Boston Scientific Neuromodulation · 2020
  • K201618Nalu Neurostimulation SCS systemBoston Scientific Neuromodulation · 2020

https://510kreport.com/device/K141399 · printed Nov 6, 2026

Cite this page

510(k) Report. “K141399: Freedom Spinal Cord Stimulator (SCS) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141399

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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