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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Media, Coupling, Ultrasound
510(k) Number K252337
Device Name EdgeFlow Gel Pad
Applicant
Edgecare, Inc.
403, Teilhard Hall, 35, Baekbeom-Ro, Mapo-Gu
Seoul,  KR 04107
Applicant Contact Beom Ki Cha
Correspondent
Edgecare, Inc.
12F, 8 Yangpyeong-ro 25-gil, Yeongdeungpo-gu
Seoul,  KR 04107
Correspondent Contact Beom Ki Cha
Regulation Number892.1570
Classification Product Code
MUI  
Date Received07/28/2025
Decision Date 04/24/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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