FDA applicant

Penner Manufacturing, Inc.

Ohaha, NE3 decisions2001–200410 recalls

FDA records 3 decisions for Penner Manufacturing, Inc. (Ohaha, NE) from 2001 to 2004: 3 510(k) clearances. All are in product code ILJ (Bath, Hydro-Massage). 10 recalls are 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 Penner Manufacturing, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Penner Manufacturing, Inc. since 2007.

Recalls per year

10in 2025

2007high 10 (2025) · low 0 (2007)2026

Class I Class II/III not classified

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

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Penner Manufacturing, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

What has been recalled?