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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 K870972
Device Name SONAFON, THERAPEUTIC MASSAGER
Applicant
Electro Medica Office
Box 3006, Stn. B
Rexdale, Ontario,  PA 
Applicant Contact JAMES MAJURY
Correspondent
Electro Medica Office
Box 3006, Stn. B
Rexdale, Ontario,  PA 
Correspondent Contact JAMES MAJURY
Regulation Number890.5975
Classification Product Code
IRO  
Date Received03/09/1987
Decision Date 04/13/1987
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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