PoNS S1-001-02

GUDID 00864288000462

PoNS System

Helius Medical, Inc

Balance therapy translingual electrical stimulation system electrode array Balance therapy translingual electrical stimulation system electrode array Balance therapy translingual electrical stimulation system electrode array Balance therapy translingual electrical stimulation system electrode array Balance therapy translingual electrical stimulation system electrode array Balance therapy translingual electrical stimulation system electrode array Balance therapy translingual electrical stimulation system electrode array Balance therapy translingual electrical stimulation system electrode array
Primary Device ID00864288000462
NIH Device Record Keyca01a229-6939-411b-93c7-79bbca247a61
Commercial Distribution StatusIn Commercial Distribution
Brand NamePoNS
Version Model Number1.1
Catalog NumberS1-001-02
Company DUNS079644962
Company NameHelius Medical, Inc
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8336131175
Emailsupport@heliusmedical.com
Phone8336131175
Emailsupport@heliusmedical.com
Phone8336131175
Emailsupport@heliusmedical.com
Phone8336131175
Emailsupport@heliusmedical.com
Phone8336131175
Emailsupport@heliusmedical.com
Phone8336131175
Emailsupport@heliusmedical.com
Phone8336131175
Emailsupport@heliusmedical.com
Phone8336131175
Emailsupport@heliusmedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100864288000462 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QCFNeuromuscular Tongue Stimulator To Treat Motor Deficits

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-06-28
Device Publish Date2022-06-20

On-Brand Devices [PoNS]

00864288000431PoNS Mouthpiece
00864288000462PoNS System

Trademark Results [PoNS]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PONS
PONS
88443666 not registered Live/Pending
Helius Medical, Inc
2019-05-23
PONS
PONS
86978547 4998391 Live/Registered
HELIUS MEDICAL, INC
2014-10-31
PONS
PONS
86819606 not registered Dead/Abandoned
Standard Textile Co., Inc.
2015-11-13
PONS
PONS
86491462 4897378 Live/Registered
Euroaliment Proveedor de Alimentos de Calidad, S.L.
2014-12-29
PONS
PONS
86440699 5845725 Live/Registered
HELIUS MEDICAL, INC
2014-10-31
PONS
PONS
79047994 3567880 Dead/Cancelled
PONS GmbH
2007-07-20
PONS
PONS
79047920 3737024 Dead/Cancelled
PONS GmbH
2007-07-20
PONS
PONS
76156320 2679697 Live/Registered
Euroaliment Proveedor de Alimentos de Calidad, S.L.
2000-10-30

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.