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 Balance therapy translingual electrical stimulation system Balance therapy translingual electrical stimulation system Balance therapy translingual electrical stimulation system Balance therapy translingual electrical stimulation system Balance therapy translingual electrical stimulation system Balance therapy translingual electrical stimulation system Balance therapy translingual electrical stimulation system Balance therapy translingual electrical stimulation system Balance therapy translingual electrical stimulation system Balance therapy translingual electrical stimulation system Balance therapy translingual electrical stimulation system Balance therapy translingual electrical stimulation system Balance therapy translingual electrical stimulation system Balance therapy translingual electrical stimulation system| 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 |
Customer Support Contacts
| Phone | 8336131175 |
| support@heliusmedical.com | |
| Phone | 8336131175 |
| support@heliusmedical.com | |
| Phone | 8336131175 |
| support@heliusmedical.com | |
| Phone | 8336131175 |
| support@heliusmedical.com | |
| Phone | 8336131175 |
| support@heliusmedical.com | |
| Phone | 8336131175 |
| support@heliusmedical.com | |
| Phone | 8336131175 |
| support@heliusmedical.com | |
| Phone | 8336131175 |
| support@heliusmedical.com | |
| Phone | 8336131175 |
| support@heliusmedical.com | |
| Phone | 8336131175 |
| support@heliusmedical.com | |
| Phone | 8336131175 |
| support@heliusmedical.com | |
| Phone | 8336131175 |
| support@heliusmedical.com | |
| Phone | 8336131175 |
| support@heliusmedical.com | |
| Phone | 8336131175 |
| support@heliusmedical.com | |
| Phone | 8336131175 |
| support@heliusmedical.com | |
| Phone | 8336131175 |
| support@heliusmedical.com | |
| Phone | 8336131175 |
| support@heliusmedical.com | |
| Phone | 8336131175 |
| support@heliusmedical.com | |
| Phone | 8336131175 |
| support@heliusmedical.com | |
| Phone | 8336131175 |
| support@heliusmedical.com | |
| Phone | 8336131175 |
| support@heliusmedical.com | |
| Phone | 8336131175 |
| support@heliusmedical.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00864288000462 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- deNovo: DEN200050
FDA Product Code
| QCF | Neuromuscular Tongue Stimulator To Treat Motor Deficits |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-06-28 |
| Device Publish Date | 2022-06-20 |
On-Brand Devices [PoNS]
| 00864288000431 | PoNS Mouthpiece |
| 00864288000462 | PoNS System |
Trademark Results [PoNS]
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 |
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