FDA Registration
Active
🇺🇸 United States
NORAXON USA, INC.
Reg #: 2084126
·
FEI: 2084126
·
Expires 2026
Products
4
Proprietary Names
19
Establishment Types
3
Classifications
4
Registration Details
- Registration Name
- NORAXON USA, INC.
- Registration Number
- 2084126
- FEI Number
- 2084126
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 15770 N Greenway Hayden Loop, No. 100
- City
- SCOTTSDALE
- State
- AZ
- ZIP
- 85260
- Country
- US
Owner / Operator
- Firm Name
- NORAXON USA, INC.
- Operator Number
- 2084126
- Address
- 15770 North Greenway-Hayden Loop, Suite 100
- City
- Scottsdale
- State
- AZ
- Postal Code
- 85260
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Goniometer, Ac-Powered | KQX | Class 1 | Orthopedic | No | 2012-07-24 |
| Transducer, Miniature Pressure | IKE | Class 1 | Physical Medicine | No | 2012-07-24 |
| Goniometer, Nonpowered | KQW | Class 1 | Orthopedic | No | 2013-11-08 |
| Device, Biofeedback | HCC | Class 2 | Neurology | No | 1998-02-19 |
Proprietary Names
Ultium Motion
MyoMotion
PhysTread
GaiTread
KinTread
forZe
MyoPressure
MyoVideo
MyoTrace 400
TeleMyo 2400 G2
MyoSystem 1400A/L
TeleMyo Clinical DTS
TeleMyo Desktop DTS
TeleMyo Mini DTS
Ultium EMG System
TeleMyo DTS
Dual EMG Ag/AgCl Electrodes
myoMUSCLE
Core EMG System
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility