510(k) Report

FDA applicant

Stimwave Technologies Incorporated

Pompano Beach, FL9 decisions2014–20190 recalls

FDA records 9 decisions for Stimwave Technologies Incorporated (Pompano Beach, FL) from 2014 to 2019: 9 510(k) clearances. All are in product code GZB (Stimulator, Spinal-Cord, Implanted (Pain Relief)). Its devices cite 18 predicates, 10 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Stimwave Technologies, Inc.”.

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

FIG. A — Illustration, neurology panel, where it files most

How often FDA has decided Stimwave Technologies Incorporated’s devices, and how often a recall has named them.

FDA decisions per year

2in 2019

2014: 12015: 12016: 22017: 22018: 12019: 2
2014high 2 (2016) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Stimwave Technologies Incorporated by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • GZBStimulator, Spinal-Cord, Implanted (Pain Relief)9decisions

Whose devices does it build on?

Its devices cite 18 predicates; 10 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 15 times; 10 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K141399Freedom Spinal Cord Stimulator (SCS) SystemStimwave Technologies Incorporated · 20145cite it
  • K150517Freedom Spinal Cord Stimulator SystemStimwave Technologies Incorporated · 20153cite it
  • K170141Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger KitStimwave Technologies Incorporated · 20173cite it
  • K172644Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, Loading BaseStimwave Technologies Incorporated · 20171cites it
  • K162161Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger KitStimwave Technologies Incorporated · 20161cites it
  • K160600Freedom Spinal Cord Stimulator SystemStimwave Technologies Incorporated · 20161cites it

What has FDA decided for it lately?

  • K191466SandShark Injectable Anchor (SIA) SystemStimwave Technologies, Inc. · 2019
  • 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
  • K160600Freedom Spinal Cord Stimulator SystemStimwave Technologies Incorporated · 2016
  • K150517Freedom Spinal Cord Stimulator SystemStimwave Technologies Incorporated · 2015

All 8 as Stimwave Technologies Incorporated →The one decision as Stimwave Technologies, Inc. →

Other applicant names beginning “Stimwave”

FDA records each applicant name separately; these may or may not be the same firm.

Stimwave Technologies Inc., Dba Stimq, LLC 1