MyOnyx Mobile App

GUDID 07540191000548

Technologie de Pensée Ltée

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 07540191000548
• NIH Device Record Key: 98a244cc-a44c-480f-839f-683ea11fe223
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MyOnyx Mobile App
• Version Model Number: SA9013
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07540191000548 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K053266

FDA Product Code

• IPF: Stimulator, Muscle, Powered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-11-20
• Device Publish Date: 2019-11-01

On-Brand Devices [MyOnyx Mobile App]

• 07540191000548: SA9013
• 07540191000586: SA9030