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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Anti-Snoring
510(k) Number K252161
Device Name Hushd Avera
Applicant
Good Sleep CO Pte , Ltd.
105 Cecil St.
#18-18, The Octagon
Singapore,  SG 069534
Applicant Contact Alwin Ngai
Correspondent
Aztech Regulatory & Quality, LLC
543 Long Hill Ave.
Shelton,  CT  06484
Correspondent Contact Joseph Azary
Regulation Number872.5570
Classification Product Code
LRK  
Date Received07/10/2025
Decision Date 11/25/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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