AccessGUDID - DEVICE: Kinesis QTUG (05391542950003)

GUDID

Device Identifier (DI) Information

Brand Name: Kinesis QTUG
Version or Model: 3.2.2
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: KINESIS

Primary DI Number: 05391542950003
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 985574496 *Terms of Use

Device Description: QTUG consists of a device for assessment of mobility, falls risk and frailty in older adults through quantitative analysis of movement using body-worn inertial sensors. The device streams data over a Bluetooth interface to an Android tablet device.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35757	Gait analysis system	An assembly of mains electricity (AC-powered) devices and instruments intended to be used to study walking or running patterns. The device uses a platform/mat that measures ground reaction forces or relative pressures (e.g., foot pressure mapping), and/or uses cameras to determine knee, ankle, and hip joint movements and to measure forces and torques. It can be used to diagnose problems related to walking or running and to help plan corrective actions.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PJP	Fall Prevention Alarm/Sensor Attached Only

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a4ed5358-2d49-4cf8-b9c6-cd97561e70c7
Public Version Date: March 02, 2023
Public Version Number: 1
DI Record Publish Date: February 22, 2023