DEVICE: Kinesia One (00859584006119)
Device Identifier (DI) Information
Kinesia One
360-0040, Application Software
In Commercial Distribution
Great Lakes Neurotechnologies Inc.
360-0040, Application Software
In Commercial Distribution
Great Lakes Neurotechnologies Inc.
Kinesia One, Application Software
Device Characteristics
Labeling does not contain MRI Safety Information | |
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? |
---|---|---|---|---|
32546 | Tremor transducer |
A device used together with a parent device (e.g., a tremograph) for the measurement of the degree of tremor caused by certain diseases. This can be useful in the diagnosis of certain movement disorders, such as essential tremor and tremor in Parkinson's disease. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GYD | Transducer, Tremor |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K063872 | 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
3be7916a-2d40-4f1d-84c0-10ad959c865a
March 03, 2021
4
September 13, 2016
March 03, 2021
4
September 13, 2016
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
[?]
216-619-5918
mphillips@glneurotech.com
mphillips@glneurotech.com