KinetikOS

GUDID 05600638781828

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.

KINETIKOS - DRIVEN SOLUTIONS, S.A.

Biomechanical function analysis/rehabilitation software

• Primary Device ID: 05600638781828
• NIH Device Record Key: 257b94b9-0860-4918-94fe-263516623426
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KinetikOS
• Version Model Number: 0,1
• Company DUNS: 338226286
• Company Name: KINETIKOS - DRIVEN SOLUTIONS, S.A.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	05600638781828 [Primary]

FDA Product Code

• ISD: Exerciser, Measuring

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-11-30
• Device Publish Date: 2022-11-22

Devices Manufactured by KINETIKOS - DRIVEN SOLUTIONS, S.A.

• 05600638781835 - KinetikosMovD: 2023-11-21
• 05600638781828 - KinetikOS: 2022-11-30The 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.
• 05600638781828 - KinetikOS: 2022-11-30 The KinetikOS software is a cloud-based software as a medical device (SaMD) that utilizes data generated by various sensors from