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
Phone
801 9746647

Products

Device Name Product Code
Hand, External Limb Component, Powered IQZ

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