TABLEGARD PRESSURE RELIEVING PATIENT WARMING MATTRESS, MODEL: TG 700 HT— 510(k) K080763

Name: FDA 510(k) clearance K080763
Creator: U.S. Food and Drug Administration
Published: 2008-05-30

Substantially Equivalent

Talley Medical

FDA 510(k) clearance K080763 for TABLEGARD PRESSURE RELIEVING PATIENT WARMING MATTRESS, MODEL: TG 700 HT, Substantially Equivalent on 2008-05-30. Applicant: Talley Medical. Device class: 2.

Clearance details

Applicant: Talley Medical
Product code: Code DWJ
Device class: Class 2
Regulation: 21 CFR 870.5900
Advisory panel: Cardiovascular
Date received: 2008-03-18
Decision date: 2008-05-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lansing, 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.