Duns Number:053824652
Device Description: Now you can have all of these capabilities in one compact system. Surface EMG, rangeof mot Now you can have all of these capabilities in one compact system. Surface EMG, rangeof motion and muscle testing – may be purchased separately or in any combination. The modulardesign of the MES 9000 allows you to purchase any combination of modules and expand as yourpractice grows. The MES 9000 --- the modular system that enables you to do a complete, integratedevaluation with objective documentation that supports your diagnosis.
Catalog Number
-
Brand Name
MES 9000 Musculoskeletal System
Version/Model Number
N9000M
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)
-
Device labeled as "Not made with natural rubber latex"
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For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
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Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K013399,K013399,K013399,K013399
Product Code
HCC
Product Code Name
Device, Biofeedback
Public Device Record Key
883bae0f-d596-417d-9dd1-e4dd109901d5
Public Version Date
June 08, 2021
Public Version Number
4
DI Record Publish Date
September 19, 2016
Package DI Number
D792N91500
Quantity per Package
1
Contains DI Package
D792N9000M0
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
With Static EMG
| 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 |