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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)
Applicant
Chongqing Rob Linka Science and Technology Co., Ltd.
B3-2, Liangjiang Health Science And Technology City,
# 2 Yuekang Rd., Fuxing St., Beibei District
Chongqing,  CN 400700
Applicant Contact Huirong Lu
Correspondent
Guangzhou Glomed Biological Technoloy Co., Ltd.
2231, Bldg. 1, Rui Feng Center, Kaichuang Rd., Huangpu
District
Guangzhou,  CN 510000
Correspondent Contact Cassie Lee
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Codes
GZJ   IPF   NGX   NYN  
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
Predetermined Change
Control Plan Authorized		 No
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