510(k) Report

FDA applicant

Argo Medical Technologies, Inc.

Marlborough, MA1 decision2014–20140 recalls

FDA records 1 decision for Argo Medical Technologies, Inc. (Marlborough, MA) in 2014: 1 De Novo grant. All are in product code PHL (Powered Exoskeleton). 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 Argo Medical Technologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2014: 1
2014high 1 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Argo Medical Technologies, Inc. by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Argo Medical Technologies, Inc.’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?

  • PHLPowered Exoskeleton1decision

Who builds on its devices?

Later devices cite its devices 3 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.

  • DEN130034RewalkArgo Medical Technologies, Inc. · 20143cite it

What has FDA decided for it lately?

  • DEN130034RewalkArgo Medical Technologies, Inc. · 2014

The one decision as Argo Medical Technologies, Inc. →