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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 K843351
Device Name OMNISTIM II COMBIN. THERAPY SYS
Applicant
Physio Technology, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Physio Technology, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number890.5860
Classification Product Code
IMG  
Date Received08/27/1984
Decision Date 09/18/1984
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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