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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. #5 Ln. 155, Sec 3
Peishen Rd., Shenkeng Hsiang
Taipei Hsien,  TW 222
Applicant Contact ROBERT TU
Correspondent
Everyway Medical Instruments Co.,Ltd
3fl. #5 Ln. 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
Predetermined Change
Control Plan Authorized		 No
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