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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
510(k) Number K900189
Device Name CURAPULS 403 DIATHERMY UNIT
Applicant
Henley Intl.
104 Industrial Blvd.,
Sugar Land,  TX  77470
Applicant Contact HENLEY, PHD
Correspondent
Henley Intl.
104 Industrial Blvd.,
Sugar Land,  TX  77470
Correspondent Contact HENLEY, PHD
Regulation Number890.5860
Classification Product Code
IMG  
Date Received01/16/1990
Decision Date 09/18/1990
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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