FLEX ICE FREEZE PACK— 510(k) K822783

Name: FDA 510(k) clearance K822783
Creator: U.S. Food and Drug Administration
Published: 1982-10-06

Substantially Equivalent

Igloo Corp.

FDA 510(k) clearance K822783 for FLEX ICE FREEZE PACK, Substantially Equivalent on 1982-10-06. Applicant: Igloo Corp.. Device class: 1.

Clearance details

Applicant: Igloo Corp.
Product code: Code IME
Device class: Class 1
Regulation: 21 CFR 890.5700
Advisory panel: Physical Medicine
Date received: 1982-09-14
Decision date: 1982-10-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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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.