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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Transcutaneous Electrical, Aesthetic Purposes
510(k) Number K251649
Device Name Sunny Plus (Sunny)
Applicant
ShenB Co., Ltd.
Shenb Tower, 74, Achasan-Ro, Seongdong-Gu
Seoul,  KR
Applicant Contact Sunny Kang
Correspondent
Hoy and Associates Regulatory Consulting
1830 Bonnie Way
Sacramento,  CA  95825
Correspondent Contact Aubrey Thompson
Regulation Number882.5890
Classification Product Code
NFO  
Date Received05/29/2025
Decision Date 09/18/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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