PoNS

Primary DI
00810188050755
Brand
PoNS
Company
Bioness Medical, Inc.
Model
M1-001
Device description
PoNS Mouthpiece
Published
2026-07-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
QCFElectrical 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
00810188050755PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810188050755008101880507558101880507550810188050755

GMDN Terms#

Term, Definition table
TermDefinition
Balance therapy translingual electrical stimulation system electrode arrayAn 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.

Regulatory Flags#

DUNS number
119378513
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
false
Expiration date on label
true
Donation ID number
true
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
00810188050618BITS FRBIT-40002026-07-10
00810188050625BITS FRBIT-40012026-07-10
00810188050762PoNSCP-0022026-07-10
00810188050779PoNSS1-001-022026-07-10
00810188050014Vector Gait and Safety SystemVEC-10002025-07-18
00810188050021Bioness Integrated System (BITS) Bedside ConfigurationBIT-21242025-07-18
00810188050045Bioness Integrated Therapy System, BITS 3.0, BITS BalanceBIT-31552025-07-18
00810188050052L360 Thigh SystemL4T-60002025-07-18
00810188050083L300 Go SystemLG4-51002025-07-18
00810188050120L300 Go SystemL4P-50012025-07-18
00810188050175L100 Go SystemLG1-5X002025-07-18
00810188050274L300 Go SystemLG4-10002025-07-18
00810188050441H200 Wireless SystemH2W-5D002025-07-18
00810188050557Vector BaseVEC-30002025-07-18
00810188050038Bioness Integrated System (BITS) Mobile ConfigurationBIT-22242025-07-17
00810188050069L360 Thigh SystemL4T-60012025-07-17
00810188050076L300 Go SystemLG4-50002025-07-17
00810188050090L300 Go SystemLG4-5U002025-07-17
00810188050106L300 Go SystemLG4-5V002025-07-17
00810188050113L300 Go SystemL4P-51002025-07-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810188050762PoNSBioness Medical, Inc.QCF2026-07-10
00810188050779PoNSBioness Medical, Inc.QCF2026-07-10
00864288000448PoNSHelius Medical, IncQCF2024-09-30
00864288000462PoNSHelius Medical, IncQCF2022-06-20
00864288000431PoNSHelius Medical, IncQCF2022-05-02