DataLOG Management + Analysis Software (Version 10)

FDA UDI

Class I (US FDA UDI)

by Biometrics Limited

Identity

Trade Name: DataLOG Management + Analysis Software (Version 10) FDA UDI
Generic Name: Kinesiology ambulatory recorder FDA UDI
Device Name: 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 data Software is available in English, Chinese, and Japanese. FDA UDI
Model / Reference: 410xx-11 FDA UDI
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 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 data Software is available in English, Chinese, and Japanese. FDA UDI

Identifiers

Primary DI / UDI-DI: 05060481691680 FDA UDI
FDA Product Code: KQX FDA UDI
IKK FDA UDI
GMDN Term: Kinesiology ambulatory recorder FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.1500 FDA UDI
890.1925 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Kinesiology ambulatory recorder

DataLOG Management + Analysis Software (Version 10) by Biometrics Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Kinesiology ambulatory recorder.

BioStamp nPoint™ — Medidata Solutions, Inc. · Class II
Opal V2C — APDM, INC. · Class II
BioStamp® nPoint — Medidata Solutions, Inc. · Class II
Opal DataHub — eResearchTechnology, Inc. · Class II
BioStamp nPoint™ — Medidata Solutions, Inc. · Class II
BioStamp nPoint™ — Medidata Solutions, Inc. · Class II
BioStamp® — Medidata Solutions, Inc. · Class II
DONJOY — DJO, LLC · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Biometrics Limited

Sources (1)

FDA UDI 6d97bfc2-c9d5-49b2-a6f0-8f3091e00965 33 fields · synced May 30, 2026