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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 K244030
Device Name Needle Stimulator (CMNS6-1 PLUS, CMNS6-3)
Applicant
Wuxi Jiajian Medical Instrument Co., Ltd.
#35 Baiqiao Rd., Ehu Town, Xishan District
Wuxi,  CN 214116
Applicant Contact Wenqing Wang
Correspondent
Shanghai CV Technology Co., Ltd.
Rm. 805, # 19 Dongbao Rd., Songjiang Area, Shanghai
Shanghai,  CN 201613
Correspondent Contact Doris Dong
Classification Product Code
BWK  
Date Received12/30/2024
Decision Date 03/28/2025
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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