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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 the device name listed in this FDA 510(k) record. The listed applicant is Wellell, Inc.. It received FDA 510(k) clearance on 2025-05-23 under 510(k) 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. The listed applicant is Wellell, Inc.. The 510(k) number is K243023.

When did WiZARD 520 Full Face Mask receive FDA 510(k) clearance?

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

Who is the listed applicant for WiZARD 520 Full Face Mask?

The FDA 510(k) record lists Wellell, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07524517NeoSHARK: Anatomical Versus Round Facemasks for Breathing Support in Preterm and Term Newborn InfantsRECRUITING

Other records listing Wellell, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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

Related Devices (Code: BZD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253044RXiBreeze PAP System (RXiBreeze 20C)Resvent Medical Technology Co., Ltd.K253553OrionResmed CorpK254104ResScan EssentialsResmed CorpK251920Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face MaskDcstar, Inc.K253166F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)BMC Medical Co., Ltd.K252338MySleepDashSomnetics International, Inc. (Dba Transcend Inc)

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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