WARM-EE HEAT PACK— 510(k) K791684

Name: FDA 510(k) clearance K791684
Creator: U.S. Food and Drug Administration
Published: 1979-10-30

Substantially Equivalent

U.S. Export Marketing Group, Inc.

FDA 510(k) clearance K791684 for WARM-EE HEAT PACK, Substantially Equivalent on 1979-10-30. Applicant: U.S. Export Marketing Group, Inc.. Device class: 1.

Clearance details

Applicant: U.S. Export Marketing Group, Inc.
Product code: Code IME
Device class: Class 1
Regulation: 21 CFR 890.5700
Advisory panel: Physical Medicine
Date received: 1979-08-28
Decision date: 1979-10-30
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.