Axon 100318

GUDID 09413000107500

Axon Neurofeedback software Application for iOS

EXSURGO LIMITED

Psychophysiological biofeedback system

• Primary Device ID: 09413000107500
• NIH Device Record Key: e8990b44-b83f-4868-ba70-82c651dc92ff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Axon
• Version Model Number: iOS
• Catalog Number: 100318
• Company DUNS: 594916540
• Company Name: EXSURGO LIMITED
• 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: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	09413000107500 [Primary]

FDA Product Code

• HCC: Device, Biofeedback

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: 2025-01-23
• Device Publish Date: 2025-01-15

On-Brand Devices [Axon]

• 09413000078459: EEG Biofeedback (Neurofeedback) Kit - Large includes Axon EEG headset - Large, Tablet with Axon
• 09413000078442: Neurofeedback Kit - Medium includes Axon EEG headset - Medium, Tablet with Axon Neurofeedback So
• 09413000078435: Neurofeedback Kit - Small includes Axon EEG headset - Small, Tablet with Axon Neurofeedback Soft
• 09413000078428: EEG Headset - Large
• 09413000078411: EEG Headset - Small
• 09413000077094: EEG Headset - Medium
• 09413000078510: Neurofeedback Software Application for Android
• 09413000107500: Axon Neurofeedback software Application for iOS