510(k) Report

FDA applicant

Vision Quest Industries, Inc.

Irvine, CA6 decisions1998–20150 recalls

FDA records 6 decisions for Vision Quest Industries, Inc. (Irvine, CA) from 1998 to 2015: 6 510(k) clearances. Most are in product codes IPF (Stimulator, Muscle, Powered) and GXY (Electrode, Cutaneous). Its devices cite 8 predicates, 2 of them its own earlier devices. No recall is 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 Vision Quest Industries, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2008: 12009: 12015: 1
2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Vision Quest Industries, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Vision Quest Industries, Inc.’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?

  • IPFStimulator, Muscle, Powered3decisions
  • GXYElectrode, Cutaneous1decision
  • NYNStimulator, Electrical, Transcutaneous, For Arthritis1decision
  • GZJStimulator, Nerve, Transcutaneous, For Pain Relief1decision

Whose devices does it build on?

Its devices cite 8 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 2 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.

  • K982388Surgi StimVision Quest Industries, Inc. · 19982cite it
  • K030507T.E.a.R. TECH3 Model #44TT03Vision Quest Industries, Inc. · 20032cite it
  • K090532T.E.a.R. TECH3Vision Quest Industries, Inc. · 20091cites it

What has FDA decided for it lately?

  • K142236BioniCare Hand SystemVision Quest Industries, Inc. · 2015
  • K090532T.E.a.R. TECH3Vision Quest Industries, Inc. · 2009
  • K072799Target Sterile ElectrodeVision Quest Industries, Inc. · 2008
  • K041092Fast Start Tens, Model FS 3001Vision Quest Industries, Inc. · 2004
  • K030507T.E.a.R. TECH3 Model #44TT03Vision Quest Industries, Inc. · 2003
  • K982388Surgi StimVision Quest Industries, Inc. · 1998

All 6 as Vision Quest Industries, Inc. →