WiZARD 520 Full Face Mask
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by Wellell Inc.
Identity
- Trade Name
- WiZARD 520 EUDAMED
- Device Name
- Full Face Mask EUDAMED
- Model / Reference
- WiZARD 520 EUDAMEDSM12003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719893347241 EUDAMED
- Basic UDI-DI
- B-04719893347241 EUDAMED
- 510(k) Number
- K243023 FDA 510(k)
- FDA Product Code
- BZD FDA 510(k)
- EMDN Code
- R0301010201 CPAP MASKS EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5905 FDA 510(k)
- Regulation Number
- 868.5905 FDA 510(k)
- Market of Registration
- Spain EUDAMED
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
The WiZARD 520 Full Face Mask is a ventilator interface designed for use with non-continuous (respiratory) devices. It provides a sealed connection between a patient’s face and a ventilator or anesthesia system, ensuring effective gas delivery and pressure support during mechanical ventilation or anesthesia procedures. Constructed as a full-face design, it covers both the nose and mouth to minimize air leakage and improve patient-ventilator synchrony.
This device is intended for single-use in clinical settings, including operating rooms and intensive care units, where sterile conditions are critical. It is classified as a Class II medical device under FDA regulations and has received FDA 510(k) clearance and MDD compliance. The mask is supplied sterile and must be discarded after one use to maintain infection control standards. No specific MRI safety information is provided, but its use should comply with facility protocols for magnetic resonance environments.
Frequently asked questions
What clinical settings is the WiZARD 520 Full Face Mask intended for use in, and why is this important?
The WiZARD 520 Full Face Mask is designed for sterile clinical environments like operating rooms and intensive care units, where mechanical ventilation or anesthesia procedures are performed. This is important because it ensures a sealed connection between the patient and the ventilator or anesthesia system, minimizing air leakage and improving patient-ventilator synchrony. Its single-use nature also helps maintain infection control standards, which is critical in high-risk settings.
Is the WiZARD 520 Full Face Mask reusable, and if not, what are the implications for infection control?
No, the WiZARD 520 Full Face Mask is explicitly intended for single-use only. This design choice directly supports infection control protocols, as reuse could introduce cross-contamination risks between patients. Discarding it after one use aligns with clinical best practices for maintaining sterile conditions during ventilation or anesthesia.
How is the WiZARD 520 Full Face Mask supplied, and what should clinicians verify before use?
The WiZARD 520 Full Face Mask is supplied sterile by the manufacturer. Clinicians should verify the sterility seal or packaging integrity before use to ensure it remains uncontaminated. Since it’s single-use, any breach in sterility necessitates discarding the mask and using a new one.
What regulatory pathways has the WiZARD 520 Full Face Mask undergone, and how does this affect its use?
The WiZARD 520 has received FDA 510(k) clearance and complies with the MDD (Medical Device Directive). This means it has undergone regulatory review to demonstrate safety and effectiveness for its intended use as a ventilator interface in anesthesia or mechanical ventilation. Clinicians can rely on these clearances to confirm its compliance with U.S. and EU standards, though local facility protocols should still govern its application.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K243023 | Class II | Active |
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Manufacturer
- Manufacturer
- Wellell Inc.
- FDA Applicant
- Wellell, Inc.
Sources (2)
- FDA 510(k) K243023 24 fields · synced Sep 18, 2026
- EUDAMED 78472355-e6b5-4daa-9bd2-7436f99962d9 61 fields · synced Jul 14, 2026