Axon 2 100500

GUDID 09413000095982

EEG-based Neurofeedback Headset for use with the Axon mobile App, enabling users to modulate and redirect brain activity towards frequencies associated with relaxation and calm focused attention.

EXSURGO LIMITED

Psychophysiological biofeedback system

• Primary Device ID: 09413000095982
• NIH Device Record Key: 4ddb9e77-5b8a-4943-8061-fc4f30b538c9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Axon 2
• Version Model Number: 100500
• Catalog Number: 100500
• 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: false
• Serial Number: true
• Manufacturing Date: true
• 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

Customer Support Contacts

• Phone: +6492183583
• Email: info@exsurgo.com
• Phone: +6492183583
• Email: info@exsurgo.com
• Phone: +6492183583
• Email: info@exsurgo.com
• Phone: +6492183583
• Email: info@exsurgo.com
• Phone: +6492183583
• Email: info@exsurgo.com
• Phone: +6492183583
• Email: info@exsurgo.com
• Phone: +6492183583
• Email: info@exsurgo.com
• Phone: +6492183583
• Email: info@exsurgo.com
• Phone: +6492183583
• Email: info@exsurgo.com
• Phone: +6492183583
• Email: info@exsurgo.com
• Phone: +6492183583
• Email: info@exsurgo.com
• Phone: +6492183583
• Email: info@exsurgo.com
• Phone: +6492183583
• Email: info@exsurgo.com
• Phone: +6492183583
• Email: info@exsurgo.com
• Phone: +6492183583
• Email: info@exsurgo.com
• Phone: +6492183583
• Email: info@exsurgo.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 131 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	09413000095982 [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: 2023-05-30
• Device Publish Date: 2023-05-22

Devices Manufactured by EXSURGO LIMITED

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• 09413000095982 - Axon 2: 2023-05-30 EEG-based Neurofeedback Headset for use with the Axon mobile App, enabling users to modulate and redirect brain activity towards
• 09413000078510 - Axon: 2021-08-24 Neurofeedback Software Application for Android
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• 09413000078411 - Axon: 2021-08-23 EEG Headset - Small
• 09413000078428 - Axon: 2021-08-23 EEG Headset - Large
• 09413000078435 - Axon: 2021-08-23 Neurofeedback Kit - Small includes Axon EEG headset - Small, Tablet with Axon Neurofeedback Software Application
• 09413000078442 - Axon: 2021-08-23 Neurofeedback Kit - Medium includes Axon EEG headset - Medium, Tablet with Axon Neurofeedback Software Application