HOT OR HEAT PACK— 510(k) K853148

Name: FDA 510(k) clearance K853148
Creator: U.S. Food and Drug Administration
Published: 1985-09-25

Substantially Equivalent

Matrix Intl.

FDA 510(k) clearance K853148 for HOT OR HEAT PACK, Substantially Equivalent on 1985-09-25. Applicant: Matrix Intl.. Device class: 1.

Clearance details

Applicant: Matrix Intl.
Product code: Code IMD
Device class: Class 1
Regulation: 21 CFR 890.5710
Advisory panel: Physical Medicine
Date received: 1985-07-29
Decision date: 1985-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boston, MA, US

Download summary PDF View on FDA.gov ↗

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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.