KinetikOS

Basic Information

• Brand Name: KinetikOS
• Primary DI: 05600638781828
• Version / Model: 0,1
• Company Name: KINETIKOS - DRIVEN SOLUTIONS, S.A.
• Labeler DUNS: 338226286
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-22
• Public Version: 2
• Public Version Date: 2024-02-05
• Public Version Status: Update
• Public Device Record Key: 257b94b9-0860-4918-94fe-263516623426

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

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
ISD	Exerciser, Measuring	Physical Medicine	890.5360	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05600638781828	GS1