GERATHERM SOS-RESCUE BLANKET— 510(k) K051097

Name: FDA 510(k) clearance K051097
Creator: U.S. Food and Drug Administration
Published: 2006-02-24

Substantially Equivalent

Rg Ent., Inc.

FDA 510(k) clearance K051097 for GERATHERM SOS-RESCUE BLANKET, Substantially Equivalent on 2006-02-24. Applicant: Rg Ent., Inc.. Device class: 2.

Clearance details

Applicant: Rg Ent., Inc.
Product code: Code DWJ
Device class: Class 2
Regulation: 21 CFR 870.5900
Advisory panel: Cardiovascular
Date received: 2005-04-29
Decision date: 2006-02-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Southfield, MI, US

Download summary PDF View on FDA.gov ↗

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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.