EQUATOR CONVECTIVE WARMER, SNUGGLE WARM ADULT FULL BODY CONVECTIVE WARMING BLANKET, SNUGGLE WARM PEDIATRICFULL BODY— 510(k) K141686

Substantially Equivalent

Smith Medical Asd, Inc.

FDA 510(k) clearance K141686 for EQUATOR CONVECTIVE WARMER, SNUGGLE WARM ADULT FULL BODY CONVECTIVE WARMING BLANKET, SNUGGLE WARM PEDIATRICFULL BODY, Substantially Equivalent on 2014-10-28. Applicant: Smith Medical Asd, Inc..

Clearance details

Applicant: Smith Medical Asd, Inc.
Product code: Code DWJ
Advisory panel: Cardiovascular
Date received: 2014-06-23
Decision date: 2014-10-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Paul, MN, US

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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.