MyOnyx Mobile App

GUDID 07540191000586

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	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