MyOnyx

GUDID 07540191000593

Technologie de Pensée Ltée

Psychophysiological biofeedback system Psychophysiological biofeedback system Psychophysiological biofeedback system Psychophysiological biofeedback system Psychophysiological biofeedback system Psychophysiological biofeedback system Psychophysiological biofeedback system Psychophysiological biofeedback system Psychophysiological biofeedback system Psychophysiological biofeedback system Psychophysiological biofeedback system Psychophysiological biofeedback system Psychophysiological biofeedback system Psychophysiological biofeedback system Psychophysiological biofeedback system Psychophysiological biofeedback system

• Primary Device ID: 07540191000593
• NIH Device Record Key: 3ee578a8-b4a5-4a35-b90b-ffc05a7a915d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MyOnyx
• Version Model Number: SA9020
• 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	07540191000593 [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 ]

• 07540191000555: SA9000
• 07540191000593: SA9020