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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 K231318
Device Name Electromagnetic Stimulator Device(Model EM Contouring and Tesla Duet)
Applicant
Beijing ADSS Development Co., Ltd.
Room 609, F6, Building 13,
Yard 5 Tianhua Street, Daxing District,
Beijing,  CN 102600
Applicant Contact Song Ying
Correspondent
Shanghai Truthful Information Technology Co., Ltd.
RM.1801,No.161,East Lujiazui Rd.,Pudong
Shanghai,  CN 200120
Correspondent Contact Boyle Wang
Regulation Number890.5850
Classification Product Code
NGX  
Date Received05/08/2023
Decision Date 07/07/2023
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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