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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name stimulator, nerve, transcutaneous, over-the-counter
510(k) Number K221092
Device Name Transcutaneous Electrical Nerve Stimulator Model: ST-304
Shenzhen Future Electronic Co., Ltd
Bldg B. Qiangchengda Industrial Park, No. 30, Youtian Road,
Longgang District
Shenzhen,  CN 518116
Applicant Contact Zhao Qihong
Qimmiq Medical Consulting Service Co., Ltd
RM. 1711, Building K, NO. 101 Science Ave International
Creative Valley
Guangzhou,  CN 510663
Correspondent Contact You Yijie
Regulation Number882.5890
Classification Product Code
Date Received04/13/2022
Decision Date 09/13/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No