Duns Number:519969810
Device Description: The Biometrics Analysis Software is a comprehensive tool for EMG, Goniometer and associate The Biometrics Analysis Software is a comprehensive tool for EMG, Goniometer and associated sensor analysis including real-time data analysis as the data is collected. The Analysis software also contains all of the features of the Management Software: The DataLOG Management Software allows the user to set up the DataLOG communications with the computer, configure the sensors, collect and save the data. the Management software also contains the Dynamic Link Library for streaming dataSoftware is available in English, Chinese, and Japanese.
Catalog Number
-
Brand Name
DataLOG Management + Analysis Software (Version 10)
Version/Model Number
410xx-11
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
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Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
IKK
Product Code Name
System, Isokinetic Testing And Evaluation
Public Device Record Key
6d97bfc2-c9d5-49b2-a6f0-8f3091e00965
Public Version Date
March 05, 2020
Public Version Number
2
DI Record Publish Date
August 10, 2018
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 | 27 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 25 |