FDA Registration
Active
🇩🇪 Germany
Manu Sensa wrist support, skin color
Reg #: 9616494
·
FEI: 3003117657
·
Expires 2025
Products
1
Proprietary Names
17
Establishment Types
2
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 |
|---|---|---|---|---|---|
| Joint, Elbow, External Limb Component, Powered | IRE | Class 1 | Physical Medicine | No | 2005-09-26 |
Proprietary Names
Manu Sensa wrist support, skin color
DynamicArm Plus
Pressure Switch
Rhizo Arexa
Rocker Switch
Manu Arexa Pollex
Harness Pull Switch
4-Step Transducer
Manu Junior Pollex
AnalogAdapter
Linear Transducer
Manu Junior
DynamicArm
Manu Carezza
Cable Pull Switch
Manu Arexa
ErgoArm Electronic plus
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device