PoNS

Primary DI: 00864288000431
Brand: PoNS
Company: Helius Medical, Inc
Model: 1.1
Catalog number: M1-001
Device description: PoNS Mouthpiece
Published: 2022-05-02
Public version status: Update
Distribution status: Not in Commercial Distribution
MRI safety: Labeling does not contain MRI Safety Information
Rx: true
OTC: false
Sterile: false
Single use: false

Contact Domains#

heliusmedical.com

Product Codes#

Code, Name table
Code	Name
QCF	Neuromuscular Tongue Stimulator To Treat Motor Deficits

Product Code Classifications#

Code, Device, Specialty table
Code	Device	Specialty	Class
QCF	Electrical Tongue Stimulator To Treat Motor Deficits	Neurology	2

Premarket Submissions#

Submission, Supplement table
Submission	Supplement
DEN200050	000

Premarket Details#

Submission, Supplement, Device table
Submission	Supplement	Device	Applicant	Decision date	Product code
DEN200050	000	Portable Neuromodulation Stimulator (PoNS)	Helius Medical, Inc.	2021-03-26	QCF

Identifiers And Packaging#

Identifier, Type, Agency table
Identifier	Type	Agency	Package quantity	Status
00864288000431	Primary	GS1	0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifier	GTIN-14 normalized	UPC-A	EAN-13
00864288000431	00864288000431	864288000431	0864288000431

GMDN Terms#

Term, Definition table
Term	Definition
Balance therapy translingual electrical stimulation system electrode array	An arrangement of multiple electrical conductors, designed as a component of a balance therapy translingual electrical stimulation system, intended to be placed on the tongue surface to apply electrical impulses during physical therapy for balance/gait rehabilitation. It is battery-powered by a wearable pulse generator to which it is connected, whereby the combination of sensorimotor activity and tongue electrical stimulation is intended to modulate brain activity (neuromodulation), via the trigeminal nerve, to treat chronic balance/gait deficits (e.g., due to traumatic brain injury, multiple sclerosis, cerebral palsy, stroke). This is a reusable device.

Contacts#

Phone, Email table
Phone	Email
8336131175	support@heliusmedical.com

Regulatory Flags#

DUNS number: 079644962
Device count: 1
DM exempt: false
Premarket exempt: false
HCT/P: false
Kit: false
Combination product: false
Lot or batch: false
Serial number: true
Manufacturing date on label: true
Expiration date on label: false
Donation ID number: false
Contains natural rubber latex: false
No natural rubber latex: false
Sterilization required before use: false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DI	Brand	Model	Catalog	Published
00864288000448	PoNS	1.1	CP-002	2024-09-30
00864288000462	PoNS	1.1	S1-001-02	2022-06-20

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
00810188050755	PoNS	Bioness Medical, Inc.	QCF	2026-07-10
00810188050762	PoNS	Bioness Medical, Inc.	QCF	2026-07-10
00810188050779	PoNS	Bioness Medical, Inc.	QCF	2026-07-10
00864288000448	PoNS	Helius Medical, Inc	QCF	2024-09-30
00864288000462	PoNS	Helius Medical, Inc	QCF	2022-06-20