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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, For Pain Relief
510(k) Number K023231
Device Name ELFCARE DEVICE, MODELS 314A THROUGH 314G
Applicant
Mediseb , Ltd.
Beit Hapa'Amon (Box 124)
20 Hata'As St.,
Kfar Saba,  IL 44425
Applicant Contact AHAVA STEIN
Correspondent
Mediseb , Ltd.
Beit Hapa'Amon (Box 124)
20 Hata'As St.,
Kfar Saba,  IL 44425
Correspondent Contact AHAVA STEIN
Regulation Number882.5890
Classification Product Code
GZJ  
Subsequent Product Codes
ILO   IPF  
Date Received09/27/2002
Decision Date 04/04/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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