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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 K253740
Device Name TENS&EMS (HZ9151B, HZ9151C, HZ9151D)
Applicant
Hong Qiangxing (Shenzhen) Electronics Limited
2f, Yongcheng Blvd., Xicheng Industrial Area, Xixiang St.
Bao'An District
Shenzhen,  CN 518126
Applicant Contact Jiaxuan Zhou
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Code
NGX  
Date Received11/24/2025
Decision Date 12/23/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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