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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 K220150
Device Name TENS & PMS (Model: SM9126)
Applicant
Hong Qiangxing (Shen Zhen) Electronics Limited
4F, Jingcheng Building, Xicheng Industrial Zone Xixiang Road
Baoan District
Shenzhen,  CN 518126
Applicant Contact Xu Jianhua
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Code
NGX  
Date Received01/19/2022
Decision Date 02/17/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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