510(k) K962252— HEALTH O METER ELECTRIC HEATING PAD W/MASSAGE MODEL EHP4

Substantially Equivalent

Sunbeam Health Division

Clearance details

Applicant: Sunbeam Health Division
Product code: Code IRT
Advisory panel: Physical Medicine
Date received: 1996-06-12
Decision date: 1996-11-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bridgeview, IL, US

Adverse events under product code IRT

product code IRT

Injury: 668
Total: 668

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.