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

K153559 · Accelerated Care Plus (Acp) · IMG · Aug 26, 2016 · Physical Medicine

Device Facts

• Record ID: K153559
• Device Name: OmniVersa Multi-Modality Therapy System and Omnistim FX2 Professional Therapy System
• Applicant: Accelerated Care Plus (Acp)
• Product Code: IMG · Physical Medicine
• Decision Date: Aug 26, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5860
• Device Class: Class 2
• Attributes: Therapeutic

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 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 Story

OmniVersa™ and Omnistim® FX2 are multi-modality therapy systems combining electrical muscle stimulation (EMS) and ultrasound therapy. The system delivers electrical waveforms (IFC, LVPC, VMS) via electrodes and ultrasound energy via transducers. Operated by clinicians in professional settings, the device provides therapeutic stimulation and thermal/non-thermal ultrasound to treat pain, muscle dysfunction, and joint stiffness. Clinicians select parameters based on patient condition; output affects physiological processes like circulation and muscle contraction. Benefits include pain management, improved mobility, and prevention of post-surgical complications. The system functions as an adjunctive therapy tool under medical supervision.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use comparisons.

Technological Characteristics

Multi-modality system combining electrical muscle stimulator (IFC, LVPC, VMS waveforms) and ultrasound transducer. Class II device (21 CFR 890.5860). Product codes: IMG, IPF, GZJ.

Indications for Use

Indicated for patients requiring adjunctive therapy for muscle spasm relaxation, muscle re-education, prevention of disuse atrophy, post-surgical calf stimulation to prevent venous thrombosis, increased local circulation, and range of motion maintenance. Also indicated for symptomatic relief of chronic intractable pain, acute pain, post-surgical pain, and post-traumatic pain. Ultrasound component indicated for pain relief, decreased joint stiffness/contractures, and treatment of conditions including adhesive capsulitis, bursitis, myositis, soft tissue injuries, and scar tissue. Must be used under medical supervision.

Regulatory Classification

Identification

An ultrasound and muscle stimulator for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of the body ultrasonic energy at a frequency beyond 20 kilohertz and that is intended to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies. The device also passes electrical currents through the body area to stimulate or relax muscles.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular emblem with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized graphic of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 26, 2016

Accelerated Care Plus (ACP) Patrick Parker VP of Biomedical Operations and QA, FDA Official Correspondent For ACP 4999 Aircenter Circle. Ste. 103 Reno, Nevada 89502

Re: K153559

Trade/Device Name: OmniVersa™ Multi-Modality Therapy System Omnistim® FX2 Professional Therapy System Regulation Number: 21 CFR 890.5860 Regulation Name: Ultrasound and Muscle Stimulator Regulatory Class: Class II Product Code: IMG, IPF , GZJ Dated: July 14, 2016 Received: July 26, 2016

Dear Mr. Parker:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply

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with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Michael J.Hoffmann -A

- for Carlos L. Peña. PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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# Indications for Use

510(k) Number (if known) K153559

#### Device Name

OmniVersa™ Multi-Modality Therapy System Omnistim® FX2 Professional Therapy System

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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