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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 K202648
Device Name Biofeedback Nerve and Muscle Stimulator
Applicant
Shenzhen Konmed Technology Co., Ltd.
601, Bldg. B4,
Shenchengtou Creative Factory Life Science Park
Shenzhen,  CN 518118
Applicant Contact Tony No Last Name Provided
Correspondent
Feiying Drug & Medical Consulting Technical Service Group
Rm.2401 Zhenye International Business Center, # 3101-90, Qia
Shenzhen,  CN 518052
Correspondent Contact Tracy Che
Regulation Number890.5850
Classification Product Code
IPF  
Subsequent Product Codes
HCC   KPI  
Date Received09/11/2020
Decision Date 12/08/2020
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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