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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 K251856
Device Name Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4
Applicant
Everyway Medical Instruments Co.,Ltd
8fl. #5, Lane 155, Sec.3 Beishen Rd. ,Shenkeng Dist.
New Taipei City,  TW 22203
Applicant Contact Jimmy Cheng
Correspondent
Everyway Medical Instruments Co.,Ltd
8fl. #5, Lane 155, Sec.3 Beishen Rd. ,Shenkeng Dist.
New Taipei City,  TW 22203
Correspondent Contact Jimmy Cheng
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Code
NGX  
Date Received06/17/2025
Decision Date 11/21/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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