FDA Registration
Active
🇺🇸 United States
MYOTRONICS-NOROMED, INC.
Reg #: 3014732
·
FEI: 3014732
·
Expires 2026
Products
6
Proprietary Names
6
Establishment Types
2
Classifications
6
Registration Details
- Registration Name
- MYOTRONICS-NOROMED, INC.
- Registration Number
- 3014732
- FEI Number
- 3014732
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 5870 S. 194TH ST.
- City
- KENT
- State
- WA
- ZIP
- 98032
- Country
- US
Regulatory Submissions
- 510(k) Number
- K013399
Owner / Operator
- Firm Name
- MYOTRONICS-NOROMED, INC.
- Operator Number
- 3014732
- Address
- 5870 S. 194TH ST., --
- City
- KENT
- State
- WA
- Postal Code
- 98032
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Device, Biofeedback | HCC | Class 2 | Neurology | No | 2005-12-14 |
| Device, Muscle Monitoring | KZM | Class 2 | Physical Medicine | No | 1992-12-31 |
| Articulators | EJP | Class 1 | Dental | No | 1992-12-31 |
| Stimulator, Muscle, Powered, Dental | NUW | Class 2 | Physical Medicine | No | 2005-12-14 |
| Device, Dental Sonography, For Monitoring Jaw Sounds | NFQ | Class 1 | Dental | No | 2005-12-14 |
| Device, Jaw Tracking, For Monitoring Jaw Positions | NFS | Class 1 | Dental | No | 2005-12-14 |
Proprietary Names
MES-9000 EMG SYSTEM
MODEL K7 EVALUATION SYSTEM
TERMINUS ARTICULATOR
MODEL J-5 MYOMONITOR
MYOTRODE SG DISPOSABLE ELECTRODES
ESG-1 ELECTROSONOGRAM
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device