510(k) Report

FDA applicant

Phoenix Medical Devices, LLC

Newport Beach, CA2 decisions2004–20120 recalls

FDA records 2 decisions for Phoenix Medical Devices, LLC (Newport Beach, CA) from 2004 to 2012: 2 510(k) clearances. Most are in product codes IPF (Stimulator, Muscle, Powered) and GXY (Electrode, Cutaneous). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Phoenix Medical Devices, Llp”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, physical medicine panel, where it files most

How often FDA has decided Phoenix Medical Devices, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2012: 1
2007high 1 (2012) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Phoenix Medical Devices, 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?

  • IPFStimulator, Muscle, Powered1decision
  • GXYElectrode, Cutaneous1decision

Whose devices does it build on?

Its devices cite 1 predicate; 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.

  • K112312TheratrodePhoenix Medical Devices, Llp · 20121cites it

What has FDA decided for it lately?

  • K112312TheratrodePhoenix Medical Devices, Llp · 2012
  • K042881PMD-2000 Interferential StimulatorPhoenix Medical Devices, LLC · 2004

The one decision as Phoenix Medical Devices, LLC →The one decision as Phoenix Medical Devices, Llp →

Other applicant names beginning “Phoenix”

FDA records each applicant name separately; these may or may not be the same firm.

Phoenix Diagnostics, Inc. 21Phoenix Biomedical Corp. 13Phoenix Medical Technology, Inc. 11Phoenix Glove Co. 6Phoenix Dental, Inc. 5Phoenix Bioengineering, Inc. 3Phoenix Innovative Healthcare Manufacturers Pvt., Ltd. 2Phoenix Biotech Corp. 2Phoenix Imaging 2Phoenix Surgical Products, Inc. 1Phoenix Management, Inc. 1Phoenix U.V.A., Ltd. 1