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FDA 510(k)

WiZARD 520 Full Face Mask

K-Number: K243023 · 2025-05-23

ApplicantWellell, Inc.
Decision Date2025-05-23
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

WiZARD 520 Full Face Mask is a medical device manufactured by Wellell, Inc.. It received FDA 510(k) clearance on 2025-05-23 under approval number K243023. The device is classified under product code BZD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WiZARD 520 Full Face Mask?

WiZARD 520 Full Face Mask is a medical device that received FDA 510(k) clearance on 2025-05-23. It is manufactured by Wellell, Inc.. The 510(k) number is K243023.

When was WiZARD 520 Full Face Mask approved by the FDA?

WiZARD 520 Full Face Mask received FDA 510(k) clearance on 2025-05-23, under approval number K243023.

What company makes WiZARD 520 Full Face Mask?

WiZARD 520 Full Face Mask is manufactured by Wellell, Inc..

What is the FDA product code for WiZARD 520 Full Face Mask?

The FDA product code for WiZARD 520 Full Face Mask is BZD.

Other Devices by Wellell, Inc.

K251466VenAir, Sequential Compression System (9P-089000); VenAir, Sequential Compression System (PM01D01 / Calf garment (S)); VenAir, Sequential Compression System (PM01E01 / Calf garment (M)); VenAir, Sequential Compression System (PM01F01 / Calf garment (L)); VenAir, Sequential Compression System (PM01G01 / Thigh garment (S)); VenAir, Sequential Compression System (PM01H01 / Thigh garment (M)); VenAir, Sequential Compression System (PM01I01 / Thigh garment (L)); VenAir, Sequential Compr

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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