DELUXE HEAT WRAP/COLD WRAP— 510(k) K801081

Substantially Equivalent

The Gillette Company

FDA 510(k) clearance K801081 for DELUXE HEAT WRAP/COLD WRAP, Substantially Equivalent on 1980-05-14. Applicant: The Gillette Company.

Clearance details

Applicant: The Gillette Company
Product code: Code IRT
Advisory panel: Physical Medicine
Date received: 1980-05-07
Decision date: 1980-05-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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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.