FDA Registration
Active
🇩🇪 Germany
System Electric Hand Digital Twin
Reg #: 9616494
·
FEI: 3003117657
·
Expires 2025
Products
1
Proprietary Names
18
Establishment Types
1
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, Powered | IQZ | Class 1 | Physical Medicine | No | 2005-09-26 |
Proprietary Names
System Electric Hand Digital Twin
7in1 Controller
System Electric Greifer DMC VariPlus
MyoCharge Integral
EnergyPack
MyoHand VariPlus Speed
bebionic Hand Short Wrist
Transcarpal Hand DMC plus
bebionic Hand Flex
SensorHand Speed
Electric Hand 2000
bebionic Hand EQD
System Electric Hand DMC Plus
Interchangeable Battery
Pulse Battery Charger
SensorHand Speed Flex
X-ChangePack
MyoEnergy Integral
Establishment Types
Export Device to the United States But Perform No Other Operation on Device