FDA Registration
Active
🇯🇵 Japan
EMG ELECTRODES AND EXTENSION CORDS
Reg #: 3013501110
·
FEI: 3013501110
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- Nihon Kohden Corporation - Tokorozawa establishment Advanced Technology Center
- Registration Number
- 3013501110
- FEI Number
- 3013501110
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1-1-6 Kusunokidai, Tokorozawa-Shi, Saitama
- City
- Tokorozawa Saitama
- Country
- JP
Regulatory Submissions
- 510(k) Number
- K870795
Owner / Operator
- Firm Name
- NIHON KOHDEN CORP.
- Operator Number
- 8030227
- Address
- 1-31-4 NISHIOCHIAI, SHINJUKU-KU
- City
- TOKYO
- State
- JP-13
- Postal Code
- 161-8560
- Country
- JP
US Agent
- Business Name
- NIHON KOHDEN AMERICA, LLC.
- Contact Name
- Charlemagne Chua
- Address
- 15353 Barranca Pkwy, --
- City
- Irvine
- State
- CA
- ZIP
- 92618
- Country
- US
- [email protected]
- Phone
- 949 3303964
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrode, Needle, Diagnostic Electromyograph | IKT | Class 2 | Physical Medicine | No | 2007-11-28 |
Proprietary Names
EMG ELECTRODES AND EXTENSION CORDS
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198