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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 K222201
Device Name Biological Feedback and Stimulation System
Applicant
Medlander Medical Technology, Inc.
Bldg. 5, Acceleration Zone,
Nanjing Life Science And Technology, Innovation Park
Nanjing,  CN 211100
Applicant Contact Wang Wang
Correspondent
Chonconn Medical Device Consulting Co., Ltd.
Rm. 504, Block C
# 1029 Nanhai Ave., Nanshan District
Shenzhen,  CN 518067
Correspondent Contact Kevin Wang
Regulation Number890.5850
Classification Product Code
IPF  
Subsequent Product Codes
HCC   KPI  
Date Received07/25/2022
Decision Date 10/21/2022
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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