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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 K112415
Device Name LIFECARE ARM & LEG PAIN RELIEF SYSTEM
Applicant
EVERYWAY MEDICAL INSTRUMENTS CO., LTD.
3FL. NO.5 LANE 155, SEC 3
PEISHEN RD, SHENKENG HSIANG
TAIPEI HSIEN,  TW 222
Applicant Contact ROBERT TU
Correspondent
EVERYWAY MEDICAL INSTRUMENTS CO., LTD.
3FL. NO.5 LANE 155, SEC 3
PEISHEN RD, SHENKENG HSIANG
TAIPEI HSIEN,  TW 222
Correspondent Contact ROBERT TU
Regulation Number882.5890
Classification Product Code
NUH  
Date Received08/22/2011
Decision Date 10/21/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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