ICE PACK, REUSABLE FLEXIBLE— 510(k) K790009

Substantially Equivalent

Ackrad Laboratories

FDA 510(k) clearance K790009 for ICE PACK, REUSABLE FLEXIBLE, Substantially Equivalent on 1979-01-22. Applicant: Ackrad Laboratories.

Clearance details

Applicant: Ackrad Laboratories
Product code: Code IME
Advisory panel: Physical Medicine
Date received: 1979-01-02
Decision date: 1979-01-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code IME

product code IME

Other: 1
Total: 1

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.