FDA Registration
Active
🇩🇪 Germany
Otto Bock Friction Wrist Unit
Reg #: 9616494
·
FEI: 3003117657
·
Expires 2025
Products
1
Proprietary Names
6
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcare GmbH
- Registration Number
- 9616494
- FEI Number
- 3003117657
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Max-Naeder-Strasse 15
- City
- DUDERSTADT Lower Saxony
- Country
- DE
Owner / Operator
- Firm Name
- Ottobock SE & Co. KGaA
- Operator Number
- 8010097
- Address
- Max-Naeder-Strasse 15
- City
- Duderstadt
- State
- Lower Saxony
- Postal Code
- 37115
- Country
- DE
US Agent
- Business Name
- Otto Bock HealthCare LP
- Contact Name
- Caleb Beck
- Address
- 3820 West Great Lakes Drive
- City
- Salt Lake City
- State
- UT
- ZIP
- 84120
- Country
- US
- [email protected]
- Phone
- 801 9746647
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Unit, Wrist, External Limb Component, Mechanical | ISZ | Class 1 | Physical Medicine | No | 2012-09-13 |
Proprietary Names
Otto Bock Friction Wrist Unit
Adaptor for 10V39
MyoWrist Transcarpal
Wrist Unit - Ratchet Type Rotation
Endoskeletal Adapter
Wrist Unit - ratchet type rotation, short
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device