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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 K872606
Device Name TELESONIC BODY STIMULATOR
Applicant
Telesonic, Inc.
2400 E. Commercial Blvd.
Fort Lauderdale,  FL  33308
Applicant Contact WILLIAM LEVY
Correspondent
Telesonic, Inc.
2400 E. Commercial Blvd.
Fort Lauderdale,  FL  33308
Correspondent Contact WILLIAM LEVY
Regulation Number890.5850
Classification Product Code
IPF  
Date Received07/02/1987
Decision Date 12/22/1987
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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