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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 K250033
Device Name Smart Pulse Relief (PZ-2622, PZ-2622T, PZ-2622E)
Applicant
Guangzhou Pinzhi Medical Technology Co., Ltd.
Rm. 501/601-1, Unit 01, Bldg. 2, Number 44,
Xiangshan Ave., Ningxi St., Zengcheng District
Guangzhou,  CN 511356
Applicant Contact XianQing Huang
Correspondent
Guangzhou GLOMED Biological Technology Co., Ltd.
2231, Bldg. 1, Rui Feng Center, Kaichuang Rd., Huangpu Distr
Guangzhou,  CN 510530
Correspondent Contact Cassie Lee
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Code
NGX  
Date Received01/07/2025
Decision Date 04/07/2025
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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