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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Electro-Acupuncture
510(k) Number K220153
Device Name Needle Stimulator (Model: RJNS6-1)
Applicant
Bozhou Rongjian Medical Appliance Co., Ltd.
Jianghuai Supply Base, Zhongkai Group, Mengcheng County
Bozhou,  CN 233500
Applicant Contact Wu Zhifang
Correspondent
Bozhou Rongjian Medical Appliance Co., Ltd.
Jianghuai Supply Base, Zhongkai Group, Mengcheng County
Bozhou,  CN 233500
Correspondent Contact Wu Zhifang
Classification Product Code
BWK  
Date Received01/19/2022
Decision Date 03/18/2022
Decision Substantially Equivalent (SESE)
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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