510(k) Report

FDA applicant

Tru-Eze Mfg. Co., Inc.

Mchenry, IL3 decisions1979–19800 recalls

FDA records 3 decisions for Tru-Eze Mfg. Co., Inc. (Mchenry, IL) from 1979 to 1980: 3 510(k) clearances. Most are in product codes IRQ (Unit, Heating, Powered) and IMA (Pack, Heat, Moist). 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 Tru-Eze Mfg. Co., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Tru-Eze Mfg. Co., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Tru-Eze Mfg. Co., Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Tru-Eze Mfg. Co., Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • IRQUnit, Heating, Powered1decision
  • IMAPack, Heat, Moist1decision
  • IMEPack, Hot Or Cold, Reusable1decision

What has FDA decided for it lately?

  • K801625Thermolator Heating UnitTru-Eze Mfg. Co., Inc. · 1980
  • K800917Tru-Cold Therapy PakTru-Eze Mfg. Co., Inc. · 1980
  • K791653Reusable Moist Heat PackTru-Eze Mfg. Co., Inc. · 1979

All 3 as Tru-Eze Mfg. Co., Inc. →