PoNS

Basic Information

• Brand Name: PoNS
• Primary DI: 00864288000448
• Version / Model: 1.1
• Catalog Number: CP-002
• Company Name: Helius Medical, Inc
• Labeler DUNS: 079644962
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-09-30
• Public Version: 1
• Public Version Date: 2024-10-08
• Public Version Status: New
• Public Device Record Key: bdd616a1-e71f-40a7-bcbc-ab311b776d62

Device Description

PoNS Controller

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QCF	Neuromuscular Tongue Stimulator To Treat Motor Deficits	Neurology	882.5889	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62980	Balance therapy translingual electrical stimulation system	An assembly of electronic devices intended to electrically stimulate the tongue during physical therapy to help rehabilitate body balance, and sometimes gait. The device may: 1) provide biofeedback for training of balance by sensing body movements and producing signals translated into electrical stimuli applied to the tongue enabling a patient to correlate electrotactile stimulation with head/body position; or 2) combine sensorimotor activity with tongue stimulation to modulate brain activity (neuromodulation), via the trigeminal nerve, and treat chronic balance/gait deficits. It consists primarily of a wearable pulse generator/controller and connected electrode array applied to the tongue.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00864288000448	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
DEN200050	000