ELASTOPLAST HEAT PLASTER— 510(k) K925630

Substantially Equivalent

Beiersdorf, Inc.

FDA 510(k) clearance K925630 for ELASTOPLAST HEAT PLASTER, Substantially Equivalent on 1994-02-25. Applicant: Beiersdorf, Inc..

Clearance details

Applicant: Beiersdorf, Inc.
Product code: Code IRT
Advisory panel: Physical Medicine
Date received: 1992-11-06
Decision date: 1994-02-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norwalk, CT, US

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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.