FDA Registration
Active
🇯🇵 Japan
Zamst EK-3
Reg #: 9614671
·
FEI: 3005319488
·
Expires 2025
Products
1
Proprietary Names
22
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- NIPPON SIGMAX CO., LTD.
- Registration Number
- 9614671
- FEI Number
- 3005319488
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1-24-1 Nishi-Shinjuku, 7th Floor
- City
- SHINJUKU-KU Tokyo
- Country
- JP
Owner / Operator
- Firm Name
- NIPPON SIGMAX CO., LTD.
- Operator Number
- 9032887
- Address
- 1-24-1 Nishi-Shinjuku, 7th Floor
- City
- Shinjuku-ku
- State
- Tokyo
- Postal Code
- 163-6033
- Country
- JP
- Correspondent
- Kennth Block
US Agent
- Business Name
- Ken Block Consulting
- Contact Name
- Kenneth L Block
- Address
- 3400 N Central Expy Ste 110265
- City
- Richardson
- State
- TX
- ZIP
- 75080
- Country
- US
- [email protected]
- Phone
- 972 4809554
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Joint, Knee, External Brace | ITQ | Class 1 | Physical Medicine | No | 1998-02-04 |
Proprietary Names
Zamst EK-3
Zamst EK-5
Zamst EK-1
Zamst RK-1 Plus
Zamst ZK-7
Zamst Filmista Knee
Zamst ZK-X
Zamst JK Band
Zamst JK-2
Zamst JK-1
ZK-Protect KNEE S
ZK-Motion KNEE M
ZK-Protect KNEE M
ZK-Protect KNEE 2XL
ZK-Protect KNEE XL
ZK-Motion KNEE 2XL
ZK-Motion KNEE S
ZK-Motion KNEE 3XL
ZK-Protect KNEE 3XL
ZK-Protect KNEE L
ZK-Motion KNEE XL
ZK-Motion KNEE L
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility