510(k) Report

FDA applicant

Newwave Medical, LLC

Plano, TX3 decisions1999–20040 recalls

FDA records 3 decisions for Newwave Medical, LLC (Plano, TX) from 1999 to 2004: 3 510(k) clearances. Most are in product codes LIH (Interferential Current Therapy) and GXY (Electrode, Cutaneous). Its devices cite 3 predicates, 0 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 Newwave Medical, LLC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Newwave Medical, LLC since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Newwave Medical, 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?

  • LIHInterferential Current Therapy1decision
  • GXYElectrode, Cutaneous1decision
  • IPFStimulator, Muscle, Powered1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 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.

  • K003631Smartwave IF 2000Newwave Medical, LLC · 20011cites it
  • K041063Smartwave MS 2000Newwave Medical, LLC · 20041cites it

What has FDA decided for it lately?

  • K041063Smartwave MS 2000Newwave Medical, LLC · 2004
  • K003631Smartwave IF 2000Newwave Medical, LLC · 2001
  • K993130Ultra-Garment ElectrodeNewwave Medical, LLC · 1999

All 3 as Newwave Medical, LLC →