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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vibrator, Therapeutic
510(k) Number K842379
Device Name ELECTRO-SAGE MODEL 203
Applicant
Weingart, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Weingart, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number890.5975
Classification Product Code
IRO  
Date Received06/18/1984
Decision Date 08/10/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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