DEVICE: OmniVersa (00858703006139)
Device Identifier (DI) Information
OmniVersa
100FXF
In Commercial Distribution
ACCELERATED CARE PLUS CORP
100FXF
In Commercial Distribution
ACCELERATED CARE PLUS CORP
Combination electrical stimulation/ultrasound for physical therapy
Device Characteristics
| Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 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.
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Active | false |
| 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.
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Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| IMG | Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat |
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| IPF | Stimulator, Muscle, Powered |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K153559 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
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| No Device Sizes |
Device Record Status
ec5f5db5-bec9-4625-a1c8-50c66ccccb24
August 25, 2023
1
August 17, 2023
August 25, 2023
1
August 17, 2023
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| No Package DIs found | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
800-850-1100
acp-customersupport@hanger.com
acp-customersupport@hanger.com