510(k) Report

FDA applicant

Tempacure Home Care

Manassas, VA1 decision1992–19920 recalls

FDA records 1 decision for Tempacure Home Care (Manassas, VA) in 1992: 1 510(k) clearance. All are in product code ILO (Pack, Hot Or Cold, Water Circulating). 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 Tempacure Home Care’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Tempacure Home Care since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Tempacure Home Care 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?

  • ILOPack, Hot Or Cold, Water Circulating1decision

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.

  • K921540Cooling/Heating Therapy DeviceTempacure Home Care · 19921cites it

What has FDA decided for it lately?

  • K921540Cooling/Heating Therapy DeviceTempacure Home Care · 1992

The one decision as Tempacure Home Care →