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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 K202861
Device Name Needle Stimulator
Applicant
Wuxi Jiajian Medical Instrument Co., Ltd
No. 35 Baiqiao Rd., Ehu Town, Xishan District,
Wuxi,  CN 214116
Applicant Contact Caihong Sun
Correspondent
Wuxi Jiajian Medical Instrument Co., Ltd
No. 35 Baiqiao Rd., Ehu Town, Xishan District,
Wuxi,  CN 214116
Correspondent Contact Caihong Sun
Classification Product Code
BWK  
Date Received09/28/2020
Decision Date 08/27/2021
Decision Substantially Equivalent (SESE)
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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