FDA applicant

Stevens Proof of Concept, Inc.

Stamford, CT1 decision2008–20080 recalls

FDA records 1 decision for Stevens Proof of Concept, Inc. (Stamford, CT) in 2008: 1 510(k) clearance. 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 Stevens Proof of Concept, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2008high 1 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

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

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

See the 510(k) Report

Stevens Proof of Concept, Inc.

Which product codes does it file in?

What has FDA decided for it lately?