# K153559: OmniVersa Multi-Modality Therapy System and Omnistim FX2 Professional Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Accelerated Care Plus (Acp)
- Decided: Aug 26, 2016 after 256 days
- Product code: IMG (Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat)
- Device class: 2
- Regulation: 21 CFR 890.5860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The OmniVersa™ Multi Modality Therapy and Omnistim® FX2 Professional Therapy Systems by ACP use the Omnistim® FX2 Stimulator for the following indications for use: • Relaxation of muscle spasms • Re-education of muscle • Prevention or retardation of disuse atrophy • Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis • Increases local circulation • Maintains or increases range of motion Stimulator waveforms; IFC, LVPC, and VMS: • Symptomatic relief and management of chronic intractable pain and as an adjunctive treatment in the management of acute pain, post-surgical pain and pain associated with post-traumatic injury. Electrical muscle stimulator devices should be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions. The OmniVersa™ Multi-Modality Therapy System also uses Omnisound® Ultrasound Transducer(s) for the following indications for use: • Relieves pain • Decreases joint stiffness and contractures • Reduction of muscle spasm • Increases local circulation • Relief of pain, muscle spasms, and joint contractures that may be associated with: adhesive capsulitis, bursitis with slight calcification, myositis, soft tissue injuries, shortened tendons due to past injuries and scar tissues • Relief of sub-chronic, chronic pain and joint contractures resulting from: capsular tightness, capsular scaring

Source page: https://510kreport.com/device/K153559
Methodology: https://510kreport.com/methodology