BARRIER EASYWARM ACTIVE SELF-WARMING BLANKET— 510(k) K132048

Substantially Equivalent

Molnlycke Health Care Us, LLC

FDA 510(k) clearance K132048 for BARRIER EASYWARM ACTIVE SELF-WARMING BLANKET, Substantially Equivalent on 2013-11-06. Applicant: Molnlycke Health Care Us, LLC.

Clearance details

Applicant: Molnlycke Health Care Us, LLC
Product code: Code DWJ
Advisory panel: Cardiovascular
Date received: 2013-07-02
Decision date: 2013-11-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norcross, GA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DWJ

product code DWJ

Death: 7
Injury: 679
Malfunction: 17,477
Total: 18,163

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.