KLIMAMED THERMAL BLANKETS, INCLUDING ARM SHOULDER WEST THERMAL BLANKET AND LEG WARMER THERMAL BLANKET— 510(k) K031728

Substantially Equivalent

Klimamed Technologie Medizingerate GmbH

FDA 510(k) clearance K031728 for KLIMAMED THERMAL BLANKETS, INCLUDING ARM SHOULDER WEST THERMAL BLANKET AND LEG WARMER THERMAL BLANKET, Substantially Equivalent on 2004-10-12. Applicant: Klimamed Technologie Medizingerate GmbH.

Clearance details

Applicant: Klimamed Technologie Medizingerate GmbH
Product code: Code DWJ
Advisory panel: Cardiovascular
Date received: 2003-06-04
Decision date: 2004-10-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Roseville, CA, 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.