Irisbond

GUDID G783OSKOL21

Oskol 2 is an Augmentative and Alternative Communication system. Oskol 2 provides a communication tool for people with oral communication difficulties, especially those with severe motor disabilities who cannot use conventional mouse-based systems. People with conditions such as Amyotrophic Lateral Sclerosis (ALS) or Cerebral Palsy can access various applications installed on the computer using Oskol 2. Oskol 2 is specifically designed for use with gaze interaction. It incorporates an eye tracker that estimates the point on the screen where the user is looking. This allows the on-screen pointer to move in time with the user's gaze, replacing traditional mouse or touch interactions. Augmentative and Alternative Communication (AAC) tools allow users to communicate effectively.

IRISBOND CROWDBONDING SL.

Voice synthesizer/digitizer

• Primary Device ID: G783OSKOL21
• NIH Device Record Key: bae829f0-68f1-4540-9620-2c7c1e6cda1c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Irisbond
• Version Model Number: Oskol2
• Company DUNS: 465408652
• Company Name: IRISBOND CROWDBONDING SL.
• 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: true
• 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: false

Customer Support Contacts

• Phone: +17633526970
• Email: support@irisbond.com
• Phone: +17633526970
• Email: support@irisbond.com
• Phone: +17633526970
• Email: support@irisbond.com
• Phone: +17633526970
• Email: support@irisbond.com
• Phone: +17633526970
• Email: support@irisbond.com
• Phone: +17633526970
• Email: support@irisbond.com
• Phone: +17633526970
• Email: support@irisbond.com
• Phone: +17633526970
• Email: support@irisbond.com
• Phone: +17633526970
• Email: support@irisbond.com
• Phone: +17633526970
• Email: support@irisbond.com
• Phone: +17633526970
• Email: support@irisbond.com
• Phone: +17633526970
• Email: support@irisbond.com
• Phone: +17633526970
• Email: support@irisbond.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	G783OSKOL20 [Primary]
HIBCC	G783OSKOL21 [Package]; Contains: G783OSKOL20; Package: Single unit box [1 Units]; In Commercial Distribution

FDA Product Code

• ILQ: System, Communication, Powered

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: 2025-08-11
• Device Publish Date: 2025-08-01