DataLITE Management + Analysis Software (Version 10)

Basic Information

• Brand Name: DataLITE Management + Analysis Software (Version 10)
• Primary DI: 05060481690867
• Version / Model: 510xx-11
• Company Name: BIOMETRICS LIMITED
• Labeler DUNS: 519969810
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-08-10
• Public Version: 1
• Public Version Date: 2018-09-10
• Public Version Status: New
• Public Device Record Key: 97bd6cb8-8940-4f4b-bbde-58e72b804664

Device Description

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 DataLITE Management Software allows the user to set up the DataLITE communications with the computer, configure the DataLITE sensors, collect and save the data. the Management software also contains the Dynamic Link Library for streaming data Software is available in English, Chinese, and Japanese.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HCC	Device, Biofeedback	Neurology	882.5050	2
IKK	System, Isokinetic Testing And Evaluation	Physical Medicine	890.1925	2
KQX	Goniometer, Ac-Powered	Orthopedic	888.1500	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44813	Bio-energy mapping system application software	An individual software program or group of programs, routines and/or algorithms, that add specific image processing and/or analysis capabilities to a computer for storing, processing, managing and displaying electronic information/data used to interpret and map bio-energy parameters. It is typically for installation in an off-the-shelf desktop or laptop computer. Data from the impulses picked up by the sensor devices are processed by the software and assimilated with a knowledge management infrastructure that assists in producing the on-screen data and analysis.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05060481690867	GS1