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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 K202470
Device Name Li-Battery powered OTC TENS/EMS, model EM-6000, EM-6100, EM-6200 & EM-6300
Applicant
Everyway Medical Instruments Co., Ltd.
3FL., No. 5, Lane 155, Section 3, Peishen Rd.,
Shenkeng District, New Taipei City,  CN 22203
Applicant Contact Paul Hung
Correspondent
Everyway Medical Instruments Co., Ltd.
3FL., No. 5, Lane 155, Section 3, Peishen Rd.,
Shenkeng District, New Taipei City,  CN 22203
Correspondent Contact Paul Hung
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Code
NGX  
Date Received08/28/2020
Decision Date 11/25/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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