510(k) Report

FDA applicant

Digital Heat Corporation

Tempe, AZ1 decision2015–20150 recalls

FDA records 1 decision for Digital Heat Corporation (Tempe, AZ) in 2015: 1 510(k) clearance. All are in product code IRT (Pad, Heating, Powered). 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 Digital Heat Corporation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2015: 1
2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Digital Heat Corporation by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Digital Heat Corporation’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?

  • IRTPad, Heating, Powered1decision

What has FDA decided for it lately?

  • K142228Heated Eye PadDigital Heat Corporation · 2015

The one decision as Digital Heat Corporation →