510(k) K153559

OmniVersa Multi-Modality Therapy System and Omnistim FX2 Professional Therapy System by Accelerated Care Plus (Acp) — Product Code IMG

K153559 is an FDA 510(k) premarket notification submitted by Accelerated Care Plus (Acp) for the device "OmniVersa Multi-Modality Therapy System and Omnistim FX2 Professional Therapy System". The FDA issued a decision of Substantially Equivalent on August 26, 2016. The device falls under product code IMG (Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat), a Class II device regulated under 21 CFR 890.5860.