510(k) Report

FDA applicant

Ivacare Corp.

Elyria, OH2 decisions1987–19930 recalls

FDA records 2 decisions for Ivacare Corp. (Elyria, OH) from 1987 to 1993: 2 510(k) clearances. Most are in product codes ITI (Wheelchair, Powered) and FNL (Bed, Ac-Powered Adjustable Hospital). 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 Ivacare Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ivacare Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Ivacare Corp. 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?

  • ITIWheelchair, Powered1decision
  • FNLBed, Ac-Powered Adjustable Hospital1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K925534Full/Semi Electric Home Care BedIvacare Corp. · 19931cites it

What has FDA decided for it lately?

  • K925534Full/Semi Electric Home Care BedIvacare Corp. · 1993
  • K865072Arrow XT Powered WheelchairIvacare Corp. · 1987

All 2 as Ivacare Corp. →