DataLINK Management + Analysis Software (Version 10) - The Biometrics Analysis Software is a - BIOMETRICS LIMITED

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 DataLINK Management Software allows the user to set up the DataLINK 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.

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More Product Details

Catalog Number

-

Brand Name

DataLINK Management + Analysis Software (Version 10)

Version/Model Number

310xx-11

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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"

-

For Single-Use

-

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 Details

Product Code

IKK

Product Code Name

System, Isokinetic Testing And Evaluation

Device Record Status

Public Device Record Key

67e8ab21-97e7-4a33-af0b-df391a324d73

Public Version Date

September 10, 2018

Public Version Number

1

DI Record Publish Date

August 10, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BIOMETRICS LIMITED" Characteristics
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