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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 K861837
Device Name FISCHER/KRYSTAL THERAPEUTIC ULTRASOUND
Applicant
Fischer Industries, Inc.
Post Office Box 570
2630 Kaneville Ct.
Geneva,  IL  60134
Applicant Contact WARREN FISCHER
Correspondent
Fischer Industries, Inc.
Post Office Box 570
2630 Kaneville Ct.
Geneva,  IL  60134
Correspondent Contact WARREN FISCHER
Regulation Number890.5860
Classification Product Code
IMG  
Date Received05/13/1986
Decision Date 08/07/1986
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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