Cleared Traditional

OmniVersa Multi-Modality Therapy System and Omnistim FX2 Professional Therapy System

K153559 · Accelerated Care Plus (Acp) · Physical Medicine

Aug 2016

Decision

256d

Days

Class 2

Risk

About This 510(k) Submission

K153559 is an FDA 510(k) clearance for the OmniVersa Multi-Modality Therapy System and Omnistim FX2 Professional Therapy System, a Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat (Class II — Special Controls, product code IMG), submitted by Accelerated Care Plus (Acp) (Reno, US). The FDA issued a Cleared decision on August 26, 2016, 256 days after receiving the submission on December 14, 2015. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5860.

Submission Details

510(k) Number	K153559 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 14, 2015
Decision Date	August 26, 2016
Days to Decision	256 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Statement

Device Classification

Product Code	IMG — Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 890.5860