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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 K935728
Device Name DYNATRON 150
Applicant
Dynatronics Corp.
7030 Park Centre Dr.
Salt Lake City,  UT  84121
Applicant Contact JOHN S RAMEY
Correspondent
Dynatronics Corp.
7030 Park Centre Dr.
Salt Lake City,  UT  84121
Correspondent Contact JOHN S RAMEY
Regulation Number890.5860
Classification Product Code
IMG  
Date Received12/01/1993
Decision Date 04/26/1994
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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