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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 K932937
Device Name DYNATRON 800
Applicant
Dynatronics Corp.
470 Lawndale Dr., Bldg.
D
Salt Lake City,  UT  84115
Applicant Contact JOHN S RAMEY
Correspondent
Dynatronics Corp.
470 Lawndale Dr., Bldg.
D
Salt Lake City,  UT  84115
Correspondent Contact JOHN S RAMEY
Regulation Number890.5860
Classification Product Code
IMG  
Date Received06/16/1993
Decision Date 10/08/1993
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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