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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 K213043
Device Name Levator Elite (Model LE9011)
Applicant
Shenzhen Dongdixin Technology Co., Ltd.
Floor 1-2, #3 Bldg., Fanshen Xusheng Industrial Estate
Xilixiaobaimang, Nanshan District
Shenzhen,  CN 518108
Applicant Contact Siping Yuan
Correspondent
Shenzhen Dongdixin Technology Co., Ltd.
Floor 1-2, #3 Bldg., Fanshen Xusheng Industrial Estate
Xilixiaobaimang, Nanshan District
Shenzhen,  CN 518108
Correspondent Contact Siping Yuan
Regulation Number890.5850
Classification Product Code
IPF  
Subsequent Product Codes
GZJ   HCC   KPI  
Date Received09/22/2021
Decision Date 02/25/2022
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
Predetermined Change
Control Plan Authorized		 No
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