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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 K232409
Device Name Electromagnetic Stimulation Systems
Applicant
Shanghai Apolo Medical Technology Co., Ltd.
Bldg. 11, Lane 1566, Nanle Rd., Songjiang District
Shanghai,  CN 201613
Applicant Contact Felix Li
Correspondent
Shanghai Apolo Medical Technology Co., Ltd.
Bldg. 11, Lane 1566, Nanle Rd., Songjiang District
Shanghai,  CN 201613
Correspondent Contact Felix Li
Regulation Number890.5850
Classification Product Code
NGX  
Date Received08/10/2023
Decision Date 04/10/2024
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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