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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stimulator, muscle, powered, for muscle conditioning
510(k) Number K231136
Device Name Fitness Belt (Model: KLT-07)
Applicant
Shenzhen KeLuTongDa Industrial Co.,Ltd.
217,44-46 Xintun South Road,Xinlian community,Longcheng
street, Longgang District
Shenzhen,  CN 518172
Applicant Contact Zhongliang Luo
Correspondent
Shanghai CV Technology Co., Ltd.
Room 602, No. 19 Dongbao Road, Songjiang Area
Shanghai,  CN 201613
Correspondent Contact Doris Dong
Regulation Number890.5850
Classification Product Code
NGX  
Date Received04/21/2023
Decision Date 06/16/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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