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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
510(k) Number K875381
Device Name ULTRASOUND DIATHERMY UNIT ULTRASOUND HEATER
Applicant
Ford Laboratories, Inc.
6908 'A' Sierra Ct.
Dublin,  CA  94568
Applicant Contact FRANKLIN C FORD
Correspondent
Ford Laboratories, Inc.
6908 'A' Sierra Ct.
Dublin,  CA  94568
Correspondent Contact FRANKLIN C FORD
Regulation Number890.5300
Classification Product Code
IMI  
Date Received12/07/1987
Decision Date 05/03/1988
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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