DataLOG MWX8

Basic Information

• Brand Name: DataLOG MWX8
• Primary DI: 05060481691789
• Version / Model: MWX8
• Catalog Number: MWX8 DataLOG - metal connectors
• 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: 2
• Public Version Date: 2020-03-05
• Public Version Status: Update
• Public Device Record Key: 4dfefba9-6b23-470e-b631-7019a64e22a8

Device Description

The DataLOG is the latest in data acquisition technology developed to meet the needs of researchers for portable data collection and monitoring in human performance, sports science, medical research, industrial ergonomics, gait laboratories, and educational settings. Includes: 8 channel data acquisition unit, Bluetooth adapter, 6 x Micro SD cards, Card reader, Management Software, instrument case This product is independently tested and certified to EN 60601-1:1990 including Amendments A1, A2 and A13

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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• 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
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
36252	Kinesiology ambulatory recorder	A battery-powered device designed to continuously measure and record a patient's kinetic activity during routine ambulation, including monitoring the motion of individual joints/limbs, typically to assess joint mobility, gait performance, and fall-risk or frailty (e.g., during post-surgery rehabilitation). It consists of a motion sensor(s) worn on the torso or a limb (e.g., thigh, calf, wrist, ankle) while performing normal daily activities, and a computing device/software to which body movement signals are transmitted for recording/analysis; it may also be attached to or integrated in an external limb prosthesis for activity monitoring.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05060481691789	GS1