510(k) Report

FDA applicant

Kjaerulff Rehabilitation A/S

Otterup, DK1 decision2004–20040 recalls

FDA records 1 decision for Kjaerulff Rehabilitation A/S (Otterup, DK) in 2004: 1 510(k) clearance. All are in product code IOR (Wheelchair, Mechanical). 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 Kjaerulff Rehabilitation A/S’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Kjaerulff Rehabilitation A/S since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Kjaerulff Rehabilitation A/S by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • IORWheelchair, Mechanical1decision

What has FDA decided for it lately?

  • K040677Combi Self Propelled Shower CommodeKjaerulff Rehabilitation A/S · 2004

The one decision as Kjaerulff Rehabilitation A/S →