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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Non-Continuous (Respirator)
510(k) Number K243023
Device Name WiZARD 520 Full Face Mask
Applicant
Wellell, Inc.
# 9, Min Sheng St.,
Tu-Cheng, New Tapei City, Taiwan
New Taipei City,  TW 236044
Applicant Contact Chieh Yang
Correspondent
Wellell, Inc.
# 9, Min Sheng St.,
Tu-Cheng, New Tapei City, Taiwan
New Taipei City,  TW 236044
Correspondent Contact Chieh Yang
Regulation Number868.5905
Classification Product Code
BZD  
Date Received09/27/2024
Decision Date 05/23/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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