510(k) Report

FDA applicant

Joerns Healthcare, Inc.

Stevens Point, WI2 decisions1995–19971 recall

FDA records 2 decisions for Joerns Healthcare, Inc. (Stevens Point, WI) from 1995 to 1997: 2 510(k) clearances. Most are in product codes ILJ (Bath, Hydro-Massage) and FNL (Bed, Ac-Powered Adjustable Hospital). Its devices cite 4 predicates, 0 of them its own earlier devices. 1 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 Joerns Healthcare, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Joerns Healthcare, Inc. since 2007.

Recalls per year

1in 2014

2014: 1
2007high 1 (2014) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Joerns Healthcare, Inc.’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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Which product codes does it file in?

  • ILJBath, Hydro-Massage1decision
  • FNLBed, Ac-Powered Adjustable Hospital1decision

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

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.

  • K964926Bath Air Spa Fixed Height Hydraulic Operated/Adjustable Height Hydraulic/Fixed Height Electric…Joerns Healthcare, Inc. · 19971cites it

What has FDA decided for it lately?

  • K964926Bath Air Spa Fixed Height Hydraulic Operated/Adjustable Height Hydraulic/Fixed Height Electric…Joerns Healthcare, Inc. · 1997
  • K951735Joerns Healthcare, Inc. Full Length Telescoping RailJoerns Healthcare, Inc. · 19951 recall

All 2 as Joerns Healthcare, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K951735Joerns EasyCare Bed Product Usage: The AC-powered adjustable hospital bed is a device…Sep 24, 2014Class II