510(k) Report

FDA applicant

Arjo Hospital Equipment AB

Roselle, IL1 decision2009–20090 recalls

FDA records 1 decision for Arjo Hospital Equipment AB (Roselle, IL) in 2009: 1 510(k) clearance. All are in product code ILJ (Bath, Hydro-Massage). 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 Arjo Hospital Equipment AB’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2009: 1
2009high 1 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Arjo Hospital Equipment AB by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Arjo Hospital Equipment AB’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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Other applicant names beginning “Arjo”

FDA records each applicant name separately; these may or may not be the same firm.