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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 K875072
Device Name MODIFIED AMANA ELECTROTHERAPEUTIC SYSTEM
Applicant
Amana Medical Group
1227 S. La Cienega Blvd.
Los Angeles,  CA  90035
Applicant Contact SHOHAYEB, MD
Correspondent
Amana Medical Group
1227 S. La Cienega Blvd.
Los Angeles,  CA  90035
Correspondent Contact SHOHAYEB, MD
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received12/09/1987
Decision Date 09/22/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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