OmniVersa

Basic Information

• Brand Name: OmniVersa
• Primary DI: 00858703006139
• Version / Model: 100FXF
• Company Name: ACCELERATED CARE PLUS CORP
• Labeler DUNS: 828331616
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-08-17
• Public Version: 1
• Public Version Date: 2023-08-25
• Public Version Status: New
• Public Device Record Key: ec5f5db5-bec9-4625-a1c8-50c66ccccb24

Device Description

Combination electrical stimulation/ultrasound for physical therapy

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IMG	Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat	Physical Medicine	890.5860	2
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	882.5890	2
IPF	Stimulator, Muscle, Powered	Physical Medicine	890.5850	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46573	Physical therapy transcutaneous neuromuscular electrical stimulation system	An electrically-powered device assembly intended to apply various modes of electrical stimulation transcutaneously to treat/prevent neuromuscular symptoms and disorders typically as a form of physical therapy [neuromuscular electrical stimulation (NMES)/electronic muscle stimulation (EMS)]; it may in addition be intended for transcutaneous electrical nerve stimulation (TENS) to treat pain, and/or electroacupuncture. It includes an electric current pulse generator and noninvasive electrodes; it is not intended for tremor suppression. Clinical applications typically include relaxation/re-education of muscles, prevention of muscle atrophy, and improvement of blood circulation.	No	Active
63504	Musculoskeletal intense therapeutic ultrasound system	An assembly of noninvasive, electrically-powered devices designed to produce and deliver intense therapeutic ultrasound (ITU) waves through the skin to create ablative lesions in subcutaneous soft tissues (e.g., muscles, tendons). High intensity ultrasound is intended to reduce inflammation and pain associated with musculoskeletal disorders or injuries (e.g., plantar fasciitis, lateral epicondylitis) by stimulating collagen production and regenerating connective tissue. The system is used by a healthcare provider and includes a console with controls/display, a handpiece with ultrasound transducers for transcutaneous energy delivery (typically at frequencies of 2-12 MHz), and handpiece tips.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00858703006139	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K153559	000