FDA applicant

Wiest USA, Inc.

Potomac, MD1 decision1991–19910 recalls

FDA records 1 decision for Wiest USA, Inc. (Potomac, MD) in 1991: 1 510(k) clearance. All are in product code IKN (Electromyograph, Diagnostic). 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 Wiest USA, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Wiest USA, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Wiest USA, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Wiest USA, 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

Wiest USA, Inc.

Which product codes does it file in?

What has FDA decided for it lately?