Duns Number:053824652
Device Description: The Dynamic SEMG module of the MES 9000 allows for the recording of up to 8 channels of SE The Dynamic SEMG module of the MES 9000 allows for the recording of up to 8 channels of SEMG simultaneously. The MES 9000 offers you the flexibility to monitor and record the data in its raw state or as integrated data.The powerful and user-friendly software simplifies the recording of multiple muscle groups of antagonist and synergist muscles to facilitate assessment and case documentation. In addition, the system includes pre-programmed protocols and analysis for assessment, muscle education and relaxation training. The clinician may also program custom protocols - quickly and simply.
Catalog Number
-
Brand Name
MES 9000 Dynamic EMG
Version/Model Number
MES 9000 EMG
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
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Device labeled as "Not made with natural rubber latex"
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For Single-Use
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Prescription Use (Rx)
-
Over the Counter (OTC)
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Kit
-
Combination Product
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Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K013399
Product Code
HCC
Product Code Name
Device, Biofeedback
Public Device Record Key
26f6028c-cd2a-483b-8c14-d03d7d115ea5
Public Version Date
June 08, 2021
Public Version Number
4
DI Record Publish Date
February 11, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |