WiZARD 520 Full Face Mask— 510(k) K243023

Substantially Equivalent

Wellell, Inc.

FDA 510(k) clearance K243023 for WiZARD 520 Full Face Mask, Substantially Equivalent on 2025-05-23. Applicant: Wellell, Inc..

Clearance details

Applicant: Wellell, Inc.
Product code: Code BZD
Advisory panel: Anesthesiology
Date received: 2024-09-27
Decision date: 2025-05-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Taipei City, TW

Download summary PDF View on FDA.gov ↗

Adverse events under product code BZD

product code BZD

Death: 4,440
Injury: 53,099
Malfunction: 213,222
Other: 17
Total: 270,778

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.