510(k) Report

FDA applicant

Powlan Manufacturing Co.

Lafayette, CA1 decision1985–19850 recalls

FDA records 1 decision for Powlan Manufacturing Co. (Lafayette, CA) in 1985: 1 510(k) clearance. All are in product code ILZ (Accessories, Traction). 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 Powlan Manufacturing Co.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Powlan Manufacturing Co. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Powlan Manufacturing Co.’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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