510(k) Report

FDA applicant

Neuromechanical Innovations, LLC

Phoenix, AZ2 decisions2003–20080 recalls

FDA records 2 decisions for Neuromechanical Innovations, LLC (Phoenix, AZ) from 2003 to 2008: 2 510(k) clearances. All are in product code LXM (Manipulator, Plunger-Like Joint). Its devices cite 10 predicates, 1 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

How often FDA has decided Neuromechanical Innovations, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2008: 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 — Neuromechanical Innovations, LLC by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LXMManipulator, Plunger-Like Joint2decisions

Whose devices does it build on?

Its devices cite 10 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 1 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.

  • K023462Impulse-Adjusting Instrument, CBP Adjusting Instrument, Neuromechanical Adjusting Instrument, Models 2003Neuromechanical Innovations, LLC · 20033cite it
  • K080261Impulse IQ Adjusting InstrumentNeuromechanical Innovations, LLC · 20082cite it

What has FDA decided for it lately?

  • K080261Impulse IQ Adjusting InstrumentNeuromechanical Innovations, LLC · 2008
  • K023462Impulse-Adjusting Instrument, CBP Adjusting Instrument, Neuromechanical Adjusting Instrument, Models 2003Neuromechanical Innovations, LLC · 2003

All 2 as Neuromechanical Innovations, LLC →