510(k) Report

FDA applicant

Stimq, LLC

Fort Lauderdale, FL1 decision2016–20166 recalls

FDA records 1 decision for Stimq, LLC (Fort Lauderdale, FL) in 2016: 1 510(k) clearance. All are in product code GZF (Stimulator, Peripheral Nerve, Implanted (Pain…). Its devices cite 5 predicates, 0 of them its own earlier devices. 6 recalls are linked to its devices.

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 Stimq, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2016: 1
2016high 1 (2016) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

6in 2020

2020: 6
2016high 6 (2020) · low 0 (2016)2026

Class I Class II/III not classified

FIG. 1 — Stimq, LLC by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Stimq, LLC’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • GZFStimulator, Peripheral Nerve, Implanted (Pain Relief)1decision

Whose devices does it build on?

Its devices cite 5 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 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.

  • K152178StimQ Peripheral Nerve Stimulator (PNS) SystemStimq, LLC · 20161cites it

What has FDA decided for it lately?

  • K152178StimQ Peripheral Nerve Stimulator (PNS) SystemStimq, LLC · 20166 recalls

The one decision as Stimq, LLC →

What has been recalled?

6 recalls linked to its devices; the latest:

  • K152178StimQ Peripheral Nerve Stimulator System (PNS) Model FR4A-TRL-AO US - Product Usage: is…Jul 15, 2020Class II
  • K152178StimQ Peripheral Nerve Stimulator System (PNS) Models: 1. FR4A-TRL-BO US and 2.…Jul 15, 2020Class II
  • K152178StimQ Peripheral Nerve Stimulator System (PNS) Models: 1. FR4A-RCV-AO US and 2.…Jul 15, 2020Class II
  • K152178StimQ Peripheral Nerve Stimulator System (PNS) Models FR4A-SPR-BO US - Product Usage: is…Jul 15, 2020Class II
  • K152178StimQ Peripheral Nerve Stimulator System (PNS) Model STQ4-SPR-BO US - Product Usage: is…Jul 15, 2020Class II
  • K152178StimQ Peripheral Nerve Stimulator System (PNS) Model 1. STQ4-RCV-A0 US and 2.STQ4-RCV-A0…Jul 15, 2020Class II