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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 K233035
Device Name Electronic Muscle Stimulator (Model MP01)
Applicant
Shenzhen Hengbosi Industrial Co., Ltd.
1035 Chuangke Building, No.72-6 Huanguan South Road,
Xintian Community, Guanhu Street, Longhua District,
Shenzhen,  CN 518000
Applicant Contact Zhiwei Chen
Correspondent
Shenzhen Hengbosi Industrial Co., Ltd.
1035 Chuangke Building, No.72-6 Huanguan South Road,
Xintian Community, Guanhu Street, Longhua District
Shenzhen,  CN 518000
Correspondent Contact Zhiwei Chen
Regulation Number890.5850
Classification Product Code
NGX  
Date Received09/25/2023
Decision Date 01/08/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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