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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Cutaneous
510(k) Number K232995
Device Name Neurological Therapy Devices - Accessories: Electrotherapy device Electrode belt for Abdominal Muscle Trainer Toning, AC1001, AC1002, AC1003, AC1003, AC1004, AC1005; Electrotherapy device Electrode belt for back of body, AC2001, AC2002, AC2003, AC2004; Electrotherapy device Electrode belt for Body joints, AC3001, AC3008, AC3009, AC3010, AC3011; Electrotherapy device Electrode for Knee, AC3002, AC3004, AC3006; Electrotherapy device Electrode for Elbow, AC3003, AC3005, AC3007; Electrothe
Applicant
Shenzhen Roundwhale Technology Co. , Ltd.
202,2/F,Bldg. 27, Dafa Industrial Park, Longxi Community,
Longgang St., Longgang District
Shenzhen,  CN 518108
Applicant Contact Zeng Chunming
Correspondent
Shenzhen Roundwhale Technology Co. , Ltd.
202,2/F,Bldg. 27, Dafa Industrial Park, Longxi Community,
Longgang St., Longgang District
Shenzhen,  CN 518108
Correspondent Contact Zou Amos
Regulation Number882.1320
Classification Product Code
GXY  
Date Received09/22/2023
Decision Date 01/11/2024
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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