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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 K233092
Device Name Pain Therapy Device (SM9075, SM9910, SM9067, SM9587W)
Chongqing Rob Linka Science and Technology Co., Ltd.
B3-2, Liangjiang Health Science And Technology City,
No. 2 Yuekang Road, Fuxing Street, Beibei District
Chongqing,  CN 400700
Applicant Contact Huirong Lu
Guangzhou GLOMED Biological Technoloy Co., Ltd.
2231, Building 1, Rui Feng Center, Kaichuang Road,
Huangpu District
Guangzhou,  CN 510000
Correspondent Contact Cassie Lee
Regulation Number882.5890
Classification Product Code
Subsequent Product Codes
Date Received09/26/2023
Decision Date 02/12/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No