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510(k) Data Aggregation
K Number
K153559Device Name
OmniVersa Multi-Modality Therapy System and Omnistim FX2 Professional Therapy System
Manufacturer
Accelerated Care Plus (ACP)
Date Cleared
2016-08-26
(256 days)
Product Code
IMG, GZJ, IPF
Regulation Number
890.5860Why did this record match?
Applicant Name (Manufacturer) :
Accelerated Care Plus (ACP)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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 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 capsultiis, 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 resular tightness, capsular scaring
Device Description
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