AccessGUDID - DEVICE: Kinesis Balance (05391542950027)

GUDID

Device Identifier (DI) Information

Brand Name: Kinesis Balance
Version or Model: 2.0.1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: KINESIS

Primary DI Number: 05391542950027
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 985574496 *Terms of Use

Device Description: Kinesis Balance is a smartphone application for assessment of balance and falls risk in older adults. The product is software based and uses simple clinical questionnaires and the sensors embedded in a smartphone to measure balance and assess risk of falls. The application is intended to be used by older adults and their carers in the home.

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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?
43115	Posturography system application software	An application software program designed for use in, or together with, a balance/mobility management system, so that it may function according to its intended purpose. This software program can be permanently installed, or exchanged as an upgrade. It may also be produced for installation in an off-the-shelf desktop or laptop computer.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JFC	System, Pressure Measurement, Intermittent

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: c6f76fb4-472d-42e8-ad86-f0c0bc24de68
Public Version Date: March 02, 2023
Public Version Number: 1
DI Record Publish Date: February 22, 2023