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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 K033140
Device Name NEUROMUSCULAR ELECTRICAL STIMULATOR, MODEL EV-807P
Applicant
Everyway Medical Instruments Co.,Ltd
1308 Morningside Park Dr.
Alpharetta,  GA  30022
Applicant Contact JAY MANSOR
Correspondent
Everyway Medical Instruments Co.,Ltd
1308 Morningside Park Dr.
Alpharetta,  GA  30022
Correspondent Contact JAY MANSOR
Regulation Number890.5850
Classification Product Code
IPF  
Date Received09/30/2003
Decision Date 10/29/2003
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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