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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
510(k) Number K171978
Device Name Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10
Applicant
Shenzhen Dongdixin Technology Co., Ltd.
No. 3 Building Xilibaimang Xusheng Industrial Estate
Nanshan
Shenzhen,  CN 518108
Applicant Contact Siping Yuan
Correspondent
Shenzhen Dongdixin Technology Co., Ltd.
No. 3 Building Xilibaimang Xusheng Industrial Estate
Nanshan
Shenzhen,  CN 518108
Correspondent Contact Siping Yuan
Regulation Number890.5850
Classification Product Code
IPF  
Subsequent Product Codes
GZJ   LIH  
Date Received06/30/2017
Decision Date 10/02/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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