PoNS

Primary DI
00864288000462
Brand
PoNS
Company
Helius Medical, Inc
Model
1.1
Catalog number
S1-001-02
Device description
PoNS System
Published
2022-06-20
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#

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
00864288000462PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00864288000462008642880004628642880004620864288000462

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.

Contacts#

Phone, Email table
PhoneEmail
8336131175support@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 DIBrandModelCatalogPublished
00864288000448PoNS1.1CP-0022024-09-30
00864288000431PoNS1.1M1-0012022-05-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810188050755PoNSBioness Medical, Inc.QCF2026-07-10
00810188050762PoNSBioness Medical, Inc.QCF2026-07-10
00810188050779PoNSBioness Medical, Inc.QCF2026-07-10
00864288000448PoNSHelius Medical, IncQCF2024-09-30
00864288000431PoNSHelius Medical, IncQCF2022-05-02