510(k) Report

FDA applicant

Innovative Neurotronics, Inc.

Austin, TX3 decisions2005–20141 recall

FDA records 3 decisions for Innovative Neurotronics, Inc. (Austin, TX) from 2005 to 2014: 3 510(k) clearances. All are in product code GZI (Stimulator, Neuromuscular, External Functional). Its devices cite 5 predicates, 2 of them its own earlier devices. 1 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 Innovative Neurotronics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2013: 12014: 1
2007high 1 (2013) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2008

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

Class I Class II/III not classified

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

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

See the 510(k) Report

Which product codes does it file in?

  • GZIStimulator, Neuromuscular, External Functional3decisions

Whose devices does it build on?

Its devices cite 5 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 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.

  • K123972Walkaide SystemInnovative Neurotronics, Inc. · 20133cite it
  • K052329Walkaide System, Models 20-0100, 20-0310, 20-1000Innovative Neurotronics, Inc. · 20052cite it
  • K140886Walkaide SystemInnovative Neurotronics, Inc. · 20141cites it

What has FDA decided for it lately?

  • K140886Walkaide SystemInnovative Neurotronics, Inc. · 2014
  • K123972Walkaide SystemInnovative Neurotronics, Inc. · 2013
  • K052329Walkaide System, Models 20-0100, 20-0310, 20-1000Innovative Neurotronics, Inc. · 20051 recall

All 3 as Innovative Neurotronics, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K052329WalkAide Stimulator System Control Module, Part Number 20-0100; component of the…Aug 6, 2008