PERSONAL WARMING GEL— 510(k) K050211

Substantially Equivalent

Qualis, Inc.

FDA 510(k) clearance K050211 for PERSONAL WARMING GEL, Substantially Equivalent on 2005-03-17. Applicant: Qualis, Inc..

Clearance details

Applicant: Qualis, Inc.
Product code: Code NUC
Advisory panel: Obstetrics/Gynecology
Date received: 2005-01-31
Decision date: 2005-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Des Moines, IA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code NUC

product code NUC

Other: 8
Total: 8

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.