510(k) Report

FDA applicant

Axiom Manufacturing

Richardson, TX2 decisions1996–19970 recalls

FDA records 2 decisions for Axiom Manufacturing (Richardson, TX) from 1996 to 1997: 2 510(k) clearances. All are in product code IPF (Stimulator, Muscle, Powered). 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, physical medicine panel, where it files most

How often FDA has decided Axiom Manufacturing’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Axiom Manufacturing since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Axiom Manufacturing 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, Powered2decisions

What has FDA decided for it lately?

  • K964423Axiom InfAxiom Manufacturing · 1997
  • K955146Axiom-HVGAxiom Manufacturing · 1996

All 2 as Axiom Manufacturing →

Other applicant names beginning “Axiom”

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

Axiom Medical, Inc. 28Axiom Worldwide, Inc. 4Axiom, Inc. 4Axiom Usa., Inc. 4Axiom Orthopaedics, Inc. 1Axiom Ent. Co., Ltd. 1Axiom Technology Partners, LLC 1