MyOnyx Mobile App

GUDID 07540191000586

Technologie de Pensée Ltée

Psychophysiological biofeedback system

• Primary Device ID: 07540191000586
• NIH Device Record Key: adb579b3-a841-43c3-a2b9-6a398b5f03aa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MyOnyx Mobile App
• Version Model Number: SA9030
• 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: true
• Serial Number: false
• 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	07540191000586 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201014

FDA Product Code

• KPI: Stimulator, Electrical, Non-Implantable, For Incontinence

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: 2023-06-15
• Device Publish Date: 2023-06-07

On-Brand Devices [MyOnyx Mobile App]

• 07540191000548: SA9013
• 07540191000586: SA9030