Biodex Corp.
United StatesFDA applicant, unverified
- Devices
- 7
What Biodex Corp. makes
Biodex Corp. manufactures physical medicine and rehabilitation equipment, including isokinetic dynamometer systems such as the Biodex System 2 and Model B-2000. Their product line also features specialized testing and training components, specifically the back system attachment and the lift simulator.
These devices are classified as Class II medical devices and are listed in the FDA 510(k) regulatory registry. The company is based in the United States.
Catalogue
Biodex System Ref K860821
Regimes: 510(k) Registry: 510(k)Biodex System 2 Autoprogram Ref K915846
Regimes: 510(k) Registry: 510(k)Biodex, Model B-2000 Ref K913021
Regimes: 510(k) Registry: 510(k)Biodex System 2, Model S2-S Ref K913020
Regimes: 510(k) Registry: 510(k)Biodex System 2 Autoprogram Ref K915648
Regimes: 510(k) Registry: 510(k)Biodex Back System Attachment Ref K900741
Regimes: 510(k) Registry: 510(k)Biodex Lift Simulator Ref K900450
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Biodex Corp. have in the registry?
The registry currently lists 7 devices for Biodex Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Biodex Corp.'s devices?
Among its 7 most recently registered devices, Biodex Corp. has devices listed in FDA 510(k) (7 devices).
What risk classes do Biodex Corp.'s devices fall under?
Among its 7 most recently registered devices, the classes recorded for Biodex Corp.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Biodex Corp. in the registry?
The most recently registered devices listed for Biodex Corp. include BIODEX SYSTEM, BIODEX SYSTEM 2 AUTOPROGRAM, BIODEX, MODEL B-2000 and BIODEX SYSTEM 2, MODEL S2-S.