PoNS S1-001-02

GUDID 00864288000462

Balance therapy translingual electrical stimulation system electrode array

Primary Device ID	00864288000462
NIH Device Record Key	ca01a229-6939-411b-93c7-79bbca247a61
Commercial Distribution Status	In Commercial Distribution
Brand Name	PoNS
Version Model Number	1.1
Catalog Number	S1-001-02
Company DUNS	079644962
Company Name	Helius Medical, Inc
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00864288000462 [Primary]

QCF	Neuromuscular Tongue Stimulator To Treat Motor Deficits

Steralize Prior To Use	false
Device Is Sterile	false

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