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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 K202849
Device Name Everyway Analog OTC TENS, model N103A/N302
Applicant
Everyway Medical Instruments Co.,Ltd
3fl., #5, Ln. 155, Section 3, Peishen Rd.,
Shenkeng District, New Taipei City,  TW 22203
Applicant Contact Paul Hung
Correspondent
Everyway Medical Instruments Co.,Ltd
3fl., #5, Ln. 155, Section 3, Peishen Rd.,
Shenkeng District, New Taipei City,  TW 22203
Correspondent Contact Paul Hung
Regulation Number882.5890
Classification Product Code
NUH  
Date Received09/28/2020
Decision Date 12/22/2020
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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