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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 K153559
Device Name OmniVersa Multi-Modality Therapy System and Omnistim FX2 Professional Therapy System
Applicant
Accelerated Care Plus (Acp)
4999 Aircenter Circle, Suite 103
Reno,  NV  89502
Applicant Contact Patrick Parker
Correspondent
Accelerated Care Plus (Acp)
4999 Aircenter Circle, Suite 103
Reno,  NV  89502
Correspondent Contact Patrick Parker
Regulation Number890.5860
Classification Product Code
IMG  
Subsequent Product Codes
GZJ   IPF  
Date Received12/14/2015
Decision Date 08/26/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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