3M HEAT COMFORT PORTABLE SELF-HEATING PAD— 510(k) K901778

Substantially Equivalent

3M Company

FDA 510(k) clearance K901778 for 3M HEAT COMFORT PORTABLE SELF-HEATING PAD, Substantially Equivalent on 1990-05-01. Applicant: 3M Company.

Clearance details

Applicant: 3M Company
Product code: Code IMD
Advisory panel: Physical Medicine
Date received: 1990-04-17
Decision date: 1990-05-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cottae Grove, MN, US

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Adverse events under product code IMD

product code IMD

Death: 3
Injury: 600
Total: 603

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.