PoNS

Primary DI
00864288000448
Brand
PoNS
Company
Helius Medical, Inc
Model
1.1
Catalog number
CP-002
Device description
PoNS Controller
Published
2024-09-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QCFNeuromuscular Tongue Stimulator To Treat Motor Deficits

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QCFElectrical Tongue Stimulator To Treat Motor DeficitsNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN200050000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN200050000Portable Neuromodulation Stimulator (PoNS)Helius Medical, Inc.2021-03-26QCF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00864288000448PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00864288000448008642880004488642880004480864288000448

GMDN Terms#

Term, Definition table
TermDefinition
Balance therapy translingual electrical stimulation systemAn 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
833-613-1175support@heliusmedical.com

Regulatory Flags#

DUNS number
079644962
Device count
1
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00864288000462PoNS1.1S1-001-022022-06-20
00864288000431PoNS1.1M1-0012022-05-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00864288000462PoNSHelius Medical, IncQCF2022-06-20
00864288000431PoNSHelius Medical, IncQCF2022-05-02