THERMAL CONDITIONING SYSTEM— 510(k) K791154

Name: FDA 510(k) clearance K791154
Creator: U.S. Food and Drug Administration
Published: 1979-10-09

Substantially Equivalent

Acurex Aerotherm

FDA 510(k) clearance K791154 for THERMAL CONDITIONING SYSTEM, Substantially Equivalent on 1979-10-09. Applicant: Acurex Aerotherm. Device class: 2.

Clearance details

Applicant: Acurex Aerotherm
Product code: Code IRT
Device class: Class 2
Regulation: 21 CFR 890.5740
Advisory panel: Physical Medicine
Date received: 1979-06-20
Decision date: 1979-10-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Recent devices under product code IRT

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Adverse events under product code IRT

product code IRT

Injury: 668
Total: 668

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.