FDA device listing
7in1 Controller,bebionic Hand EQD,bebionic Hand Flex,bebionic Hand Short Wrist,Electric Hand…
FDA device listing 1590505335 · Ottobock SE & Co. KGaA
Key facts
| Proprietary names | 7in1 Controller,bebionic Hand EQD,bebionic Hand Flex,bebionic Hand Short Wrist,Electric Hand 2000,EnergyPack,Interchangeable Battery,MyoCharge Integral,MyoEnergy Integral,MyoHand VariPlus Speed,Pulse Battery Charger,SensorHand Speed,SensorHand Speed Flex,speed.hand,System Electric Greifer DMC VariPlus,System Electric Hand Digital Twin,System Electric Hand DMC Plus,Transcarpal Hand DMC… |
|---|---|
| Owner/operator | Ottobock SE & Co. KGaA |
| Owner/operator number | 8010097 |
| Product codes | IQZ |
| Device names | IQZ - Hand, External Limb Component, Powered |
| Device class | Class I |
| Classification regulations (21 CFR) | 890.3420 |
| Review panels | Physical Medicine |
| Registered establishments | Otto Bock Healthcare Products GmbH, Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcare GmbH |
| Establishment registrations | 9616494, 3005190268 |
| FEI numbers | 3003117657, 3005190268 |
| Establishment operations | Foreign Exporter, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database