FDA Registration
Active
🇺🇸 United States
Altivera Medical, Inc.
Reg #: 3017936974
·
FEI: 3017936974
·
Expires 2026
Products
7
Proprietary Names
6
Establishment Types
2
Classifications
7
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Registration Details
- Registration Name
- Altivera Medical, Inc.
- Registration Number
- 3017936974
- FEI Number
- 3017936974
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 14800 Grasslands Drive
- City
- Englewood
- State
- CO
- ZIP
- 80112
- Country
- US
Regulatory Submissions
- 510(k) Number
- K222669
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 |
|---|---|---|---|---|---|
| Massager, Powered Inflatable Tube | IRP | Class 2 | Physical Medicine | No | 2024-06-11 |
| Pack, Hot Or Cold, Reusable | IME | Class 1 | Physical Medicine | No | 2024-06-11 |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | Class 2 | Neurology | No | 2024-10-21 |
| Stimulator, Electrical, Non-Implantable, For Incontinence | KPI | Class 2 | Gastroenterology, Urology | No | 2012-12-27 |
| Device, Biofeedback | HCC | Class 2 | Neurology | No | 2007-12-12 |
| Stimulator, Muscle, Powered | IPF | Class 2 | Physical Medicine | No | 2007-12-12 |
| Interferential Current Therapy | LIH | Class 2 | Neurology | No | 2012-12-27 |
Proprietary Names
DynaComp
TENSWave
InWave
NeuroMove NM900
M-Wave
NexWave
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device