MyOnyx

GUDID 07540191000555

Technologie de Pensée Ltée

Psychophysiological biofeedback system

• Primary Device ID: 07540191000555
• NIH Device Record Key: c5d11850-9499-4f01-8562-3dcf102e078b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MyOnyx
• Version Model Number: SA9000
• Company DUNS: 209284132
• Company Name: Technologie de Pensée Ltée
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07540191000555 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K053434

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: 2020-07-24
• Device Publish Date: 2020-07-16

On-Brand Devices [MyOnyx]

• 07540191000555: SA9000
• 07540191000593: SA9020