K780279

Substantially Equivalent

ICE-PAK, PDI

Applicant: Nice-Pak Products, Inc.
Product code: IMD
Advisory panel: Physical Medicine
Date received: 1978-02-21
Decision date: 1978-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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.