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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 K172834
Device Name Dual output digital therapy massager
Shenzhen OSTO Technology Co., Ltd.
No.43 Longfeng Road, Xinsheng Community
Longgang Street Longgang District
Shenzhen,  CN
Applicant Contact Li Yang
Guangzhou GLOMED Biological Technology Co., Ltd.
Suite 306, Kecheng Mansion, No.121 Science Road
Guangzhou Science Park
Guangzhou,  CN 510006
Correspondent Contact Cecilia Ceng
Regulation Number882.5890
Classification Product Code
Subsequent Product Code
Date Received09/19/2017
Decision Date 09/06/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No