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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 K211263
Device Name Intrelief
Applicant
EasyMed Instruments Co., Ltd.
3F, 5F-6F, Blk A, Gupo Gongmao Bld, Fengxin Rd,
Fengxiang Industrial District, Daliang, Shunde
Foshan,  CN 528300
Applicant Contact Jeffery (Tingjie Wu) Wu
Correspondent
EasyMed Instruments Co., Ltd.
3F, 5F-6F, Blk A, Gupo Gongmao Bld, Fengxin Rd,
Fengxiang Industrial District, Daliang, Shunde
Foshan,  CN 528300
Correspondent Contact Jeffery (Tingjie Wu) Wu
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Code
NGX  
Date Received04/26/2021
Decision Date 12/30/2021
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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