DEVICE: MyndMove 2.0 (00692520202004)
Device Identifier (DI) Information
MyndMove 2.0
MyndMove FES System
In Commercial Distribution
920200
MyndTec Inc
MyndMove FES System
In Commercial Distribution
920200
MyndTec Inc
No description.
Device Characteristics
MR Unsafe | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
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? |
---|---|---|---|---|
59689 | Neuromuscular transmission electrode |
A non-sterile electrical conductor designed to be applied to a patient's body surface, typically the forearm or ankle, to deliver stimulating electrical pulses to a motor nerve or measure electrical impulses from the nerve during neuromuscular transmission (NMT) monitoring. It is typically a disk-like electrode that is affixed to the skin with a special adhesive and a conductive gel (pre-gelled) intended to be used for neuromuscular block monitoring and nerve stimulation for brachial plexus anaesthesia. This is a single-use device.
|
Obsolete | false |
59690 | Neuromuscular transmission electrode/sensor lead |
A non-sterile insulated metal wire(s) designed to conduct electrical signals between neuromuscular transmission (NMT) electrodes and sensors placed on a patient's body and a patient monitoring system module, intended for the monitoring of patient relaxation to determine the level of neuromuscular block and the localization of a nerve in an area of the body. This is a reusable device.
|
Obsolete | false |
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.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
IPF | Stimulator, Muscle, Powered |
GZI | Stimulator, Neuromuscular, External Functional |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K212149 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
f9e26be1-b99a-42e8-9c54-092f2cc8fde0
June 02, 2023
2
August 19, 2022
June 02, 2023
2
August 19, 2022
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 |
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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
[?]
No Customer Contact currently defined