TRU-COLD THERAPY PAK— 510(k) K800917

Name: FDA 510(k) clearance K800917
Creator: U.S. Food and Drug Administration
Published: 1980-05-02

Substantially Equivalent

Tru-Eze Mfg. Co., Inc.

FDA 510(k) clearance K800917 for TRU-COLD THERAPY PAK, Substantially Equivalent on 1980-05-02. Applicant: Tru-Eze Mfg. Co., Inc.. Device class: 1.

Clearance details

Applicant: Tru-Eze Mfg. Co., Inc.
Product code: Code IME
Device class: Class 1
Regulation: 21 CFR 890.5700
Advisory panel: Physical Medicine
Date received: 1980-04-22
Decision date: 1980-05-02
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.