FDA Registration
Active
🇺🇸 United States
i-Limb Wrist
Reg #: 2242474
·
FEI: 2242474
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- OSSUR AMERICAS
- Registration Number
- 2242474
- FEI Number
- 2242474
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 680 Grove Rd
- City
- West Deptford
- State
- NJ
- ZIP
- 08086
- Country
- US
Owner / Operator
- Firm Name
- OSSUR Americas
- Operator Number
- 9026971
- Address
- 200 Spectrum Center Drive, Suite 700
- City
- Irvine
- State
- CA
- Postal Code
- 92618
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Unit, Wrist, External Limb Component, Powered | KGH | Class 1 | Physical Medicine | No | 2019-01-15 |
Proprietary Names
i-Limb Wrist
Establishment Types
Repack or Relabel Medical Device