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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 K031329
Device Name DYNATRON SOLARIS SERIES, MODELS 705, 706, 708, 709 D880 INFRARED PROBE (OPTIONAL ACCESSORY)
Applicant
Dynatronics Corp.
7030 Park Centre Dr.
Salt Lake City,  UT  84121
Applicant Contact RON HATCH
Correspondent
Dynatronics Corp.
7030 Park Centre Dr.
Salt Lake City,  UT  84121
Correspondent Contact RON HATCH
Regulation Number890.5300
Classification Product Code
IMI  
Subsequent Product Codes
GZJ   ILY   IPF   LIH  
Date Received04/28/2003
Decision Date 10/22/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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