Otto Bock Orthopedic Industry, Inc.
United StatesFDA applicant, unverified
- Devices
- 6
What Otto Bock Orthopedic Industry, Inc. makes
The company designs and manufactures powered and manual wheelchairs, including the C-LEG microprocessor-controlled knee joint for amputees, as well as models like the RAEBBITT, AVANTGARDE, PROTEGE, and VOYAGER/VIPER for mobility assistance. Their portfolio also includes the EVANTGARDE/ENDEAVOR powered wheelchair, tailored for active users requiring adjustable seating and propulsion.
These devices are regulated under FDA Class I and Class II classifications, with many authorised via the 510(k) pathway. The company’s products are listed in the FDA’s 510(k) database, and the manufacturer operates from the United States.
Catalogue
C-Leg (3C100) Ref K991590
Regimes: 510(k) Registry: 510(k)Raebbitt/Evolution Powered Wheelchair Ref K000678
Regimes: 510(k) Registry: 510(k)Avantgarde Ref K951847
Regimes: 510(k) Registry: 510(k)Protege Wheelchair Ref K000602
Regimes: 510(k) Registry: 510(k)Voyager/Viper Wheelchair Ref K000497
Regimes: 510(k) Registry: 510(k)Evantgarde/Endeavor Powered Wheelchair Ref K000739
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Otto Bock Orthopedic Industry, Inc. have in the registry?
The registry currently lists 6 devices for Otto Bock Orthopedic Industry, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Otto Bock Orthopedic Industry, Inc.'s devices?
Among its 6 most recently registered devices, Otto Bock Orthopedic Industry, Inc. has devices listed in FDA 510(k) (6 devices).
What risk classes do Otto Bock Orthopedic Industry, Inc.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Otto Bock Orthopedic Industry, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Otto Bock Orthopedic Industry, Inc. in the registry?
The most recently registered devices listed for Otto Bock Orthopedic Industry, Inc. include C-LEG (3C100), RAEBBITT/EVOLUTION POWERED WHEELCHAIR, AVANTGARDE and PROTEGE WHEELCHAIR.