FDA Registration
Active
🇩🇪 Germany
Hand Adaptor
Reg #: 9616494
·
FEI: 3003117657
·
Expires 2025
Products
1
Proprietary Names
21
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 |
|---|---|---|---|---|---|
| Hand, External Limb Component, Mechanical | IRA | Class 1 | Physical Medicine | No | 2014-11-03 |
Proprietary Names
Hand Adaptor
Triple-Control Above-Elbow Harness
Otto Bock System Hand -voluntary opening
Physolino Babyhand
Modular Wrist Unit
Wrist Connector of wood
Connector
Connection Piece for Hook
Connector for Hook
Modular Adapter for Arm Liners
MovoWrist Flex
O.B. Disconnect Adaptor
Otto Bock System Hand -passive-
Below-Elbow Harness
MyoWrist
MyolinoWrist 2000
Attachment Plate with Stud
Adapter with Internal Thread
Otto Bock System Hand -voluntary closing
Attachment Plate with short stud
Adapter
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device