FDA UDI
In Commercial Distribution
🇺🇸 United States
PoNS
DI: 00864288000462
·
Model: 1.1
·
Helius Medical, Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PoNS
- Primary DI
- 00864288000462
- Version / Model
- 1.1
- Catalog Number
- S1-001-02
- Company Name
- Helius Medical, Inc
- Labeler DUNS
- 079644962
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-06-20
- Public Version
- 1
- Public Version Date
- 2022-06-28
- Public Version Status
- New
- Public Device Record Key
- ca01a229-6939-411b-93c7-79bbca247a61
Device Description
PoNS System
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QCF | Neuromuscular Tongue Stimulator To Treat Motor Deficits | Neurology | 882.5889 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64270 | Balance therapy translingual electrical stimulation system electrode array | An 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00864288000462 | GS1 |
Customer Contacts
- Phone
- 8336131175
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| DEN200050 | 000 |