FDA Registration
Active
🇯🇵 Japan
NIPPON SIGMAX CO., LTD.
Reg #: 9614671
·
FEI: 3005319488
·
Expires 2026
Products
4
Proprietary Names
34
Establishment Types
1
Classifications
4
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Registration Details
- Registration Name
- NIPPON SIGMAX CO., LTD.
- Registration Number
- 9614671
- FEI Number
- 3005319488
- Status
- Active
- Expiry Year
- 2026
- 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 100265
- 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, Hip, External Brace | ITS | Class 1 | Physical Medicine | No | 2008-04-21 |
| Support, Arm | IOY | Class 1 | Physical Medicine | No | 2008-04-21 |
| Joint, Ankle, External Brace | ITW | Class 1 | Physical Medicine | No | 2007-12-24 |
| Joint, Knee, External Brace | ITQ | Class 1 | Physical Medicine | No | 1998-02-04 |
Proprietary Names
Zamst ZW-7
Zamst ZW-5
Zamst Filmista Wrist
Zamst Thumb Guard
Zamst Elbow Band
Zamst Shoulder Wrap
Zamst Wrist Band
Zamst Filmista Ankle
Zamst A2-DX
Zamst A2-DX White
Zamst A1
Zamst A1 White
Zamst RK-1 Plus
Zamst Filmista Knee
Zamst JK Band
Zamst EK-3
Zamst JK-2
Zamst EK-5
Zamst EK-1
Zamst JK-1
Zamst ZK-X
Zamst ZK-7
ZK-Protect KNEE L
ZK-Motion KNEE S
ZK-Motion KNEE XL
ZK-Protect KNEE XL
ZK-Motion KNEE 3XL
ZK-Protect KNEE 3XL
ZK-Protect KNEE 2XL
ZK-Motion KNEE 2XL
ZK-Motion KNEE M
ZK-Motion KNEE L
ZK-Protect KNEE S
ZK-Protect KNEE M
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility