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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 K261574
Device Name Wireless TENS&EMS&NMES Heating Stimulator (SM9086, SM9125, SM9141B, SM9142B, SM9143)
Applicant
Hong Qiangxing (Shenzhen) Electronics Limited
2f, Yongcheng Blvd., Xicheng Industrial Area, Xixiang St.
Bao'An District
Shenzhen,  CN 518126
Applicant Contact Zhou Jiaxuan
Correspondent
Guangzhou GLOMED Biological Technology Co., Ltd.
Rm. 2231, Bldg. 1, Ruifeng Center, Kaichuang Rd., Huangpu Di
Guangzhou,  CN 510535
Correspondent Contact Cassie Lee
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Codes
IRT   NGX   NYN  
Date Received05/12/2026
Decision Date 10/16/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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