AccessGUDID - DEVICE: KinetikOS (05600638781828)

GUDID

Device Identifier (DI) Information

Brand Name: KinetikOS
Version or Model: 0,1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: KINETIKOS - DRIVEN SOLUTIONS, S.A.

Primary DI Number: 05600638781828
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 338226286 *Terms of Use

Device Description: The KinetikOS software is a cloud-based software as a medical device (SaMD) that utilizes data generated by various sensors from portable or wearable consumer electronics such as smartphones and smartwatches and provides gait-related data analytics. Gait-related measurements and analytics are provided to compatible 3rd-party software via APIs for displaying data, generating reports, performing further analysis and/or integrating data into their digital health software or apps, for the purpose of monitoring and understanding individual user’s general mobility or gait-related health conditions by qualified healthcare providers.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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):	Yes
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?
47518	Biomechanical function analysis/rehabilitation software	A software package intended to be used by patients and clinicians to receive and display a patient’s physical exercise/movement/action data [e.g., kinesiology/gait data (walking speed or distance)] to facilitate analysis as part of physical assessment/rehabilitation. It is intended to be used while using an interactive rehabilitation system, biomechanical function analysis system and/or kinesiology recorder (ambulatory or implantable). It might be intended to function in conjunction with a motion-sensing system/device or limb-support robotic system, and may be capable of storing and/or enable viewing of patient performance data.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ISD	Exerciser, Measuring

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: 257b94b9-0860-4918-94fe-263516623426
Public Version Date: February 05, 2024
Public Version Number: 2
DI Record Publish Date: November 22, 2022