FDA Registration
Active
🇺🇸 United States
TENSWave
Reg #: 3017936974
·
FEI: 3017936974
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ZYNEX MEDICAL, INC.
- Registration Number
- 3017936974
- FEI Number
- 3017936974
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 14800 Grasslands Drive
- City
- Englewood
- State
- CO
- ZIP
- 80112
- Country
- US
Regulatory Submissions
- 510(k) Number
- K241228
Owner / Operator
- Firm Name
- ZYNEX MEDICAL, INC.
- Operator Number
- 9028838
- Address
- 9655 Maroon Circle
- City
- Englewood
- State
- CO
- Postal Code
- 80112
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | Class 2 | Neurology | No | 2024-10-21 |
Proprietary Names
TENSWave
Establishment Types
Manufacture Medical Device