510(k) Report

FDA applicant

Emsi

Alexandria, VA7 decisions2008–20220 recalls

FDA records 7 decisions for Emsi (Alexandria, VA) from 2008 to 2022: 7 510(k) clearances. Most are in product codes GZJ (Stimulator, Nerve, Transcutaneous, For Pain…) and IPF (Stimulator, Muscle, Powered). Its devices cite 7 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Emsi, Inc.”.

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 Emsi’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2008: 12009: 32010: 12014: 12022: 1
2008high 3 (2009) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Emsi by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Emsi’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?

  • GZJStimulator, Nerve, Transcutaneous, For Pain Relief3decisions
  • IPFStimulator, Muscle, Powered3decisions
  • GXYElectrode, Cutaneous1decision

Whose devices does it build on?

Its devices cite 7 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K083030Tens-Ems-14Emsi · 20091cites it

What has FDA decided for it lately?

All 6 as Emsi →The one decision as Emsi, Inc. →