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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Muscle, Powered
510(k) Number K033544
Device Name ELECTRICAL MUSCLE STIMULATOR, MODELS N605 AND N607
Applicant
Everyway Medical Instruments Co.,Ltd
1308 Morningside Park Dr.
Alpharetta,  GA  30022
Applicant Contact JAY MANSOUR
Correspondent
Everyway Medical Instruments Co.,Ltd
1308 Morningside Park Dr.
Alpharetta,  GA  30022
Correspondent Contact JAY MANSOUR
Regulation Number890.5850
Classification Product Code
IPF  
Date Received11/10/2003
Decision Date 12/10/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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