510(k) Report

FDA applicant

Eswallow USA

Guntersville, AL2 decisions2011–20130 recalls

FDA records 2 decisions for Eswallow USA (Guntersville, AL) from 2011 to 2013: 2 510(k) clearances. Most are in product codes GXY (Electrode, Cutaneous) and IPF (Stimulator, Muscle, Powered). Its devices cite 2 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 Eswallow USA’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2011: 12013: 1
2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Eswallow USA by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Which product codes does it file in?

  • GXYElectrode, Cutaneous1decision
  • IPFStimulator, Muscle, Powered1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K113375Eswallow Usa Electrode,Eswallow Usa LeadwireEswallow USA · 2013
  • K092202Eswallow Dysphagia Therapy Kit, Pmi Dysphagia Therapy KitEswallow USA · 2011

All 2 as Eswallow USA →