PoNS M1-001

GUDID 00864288000431

PoNS Mouthpiece

Helius Medical, Inc

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• Primary Device ID: 00864288000431
• NIH Device Record Key: 8c556801-9986-4365-847e-1c70590afed4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PoNS
• Version Model Number: 1.1
• Catalog Number: M1-001
• Company DUNS: 079644962
• Company Name: Helius Medical, Inc
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8336131175
• Email: support@heliusmedical.com
• Phone: 8336131175
• Email: support@heliusmedical.com
• Phone: 8336131175
• Email: support@heliusmedical.com
• Phone: 8336131175
• Email: support@heliusmedical.com
• Phone: 8336131175
• Email: support@heliusmedical.com
• Phone: 8336131175
• Email: support@heliusmedical.com
• Phone: 8336131175
• Email: support@heliusmedical.com
• Phone: 8336131175
• Email: support@heliusmedical.com
• Phone: 8336131175
• Email: support@heliusmedical.com
• Phone: 8336131175
• Email: support@heliusmedical.com
• Phone: 8336131175
• Email: support@heliusmedical.com
• Phone: 8336131175
• Email: support@heliusmedical.com
• Phone: 8336131175
• Email: support@heliusmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00864288000431 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN200050

FDA Product Code

• QCF: Neuromuscular Tongue Stimulator To Treat Motor Deficits

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: 2022-05-10
• Device Publish Date: 2022-05-02

On-Brand Devices [PoNS]

• 00864288000431: PoNS Mouthpiece
• 00864288000462: PoNS System