Aerotek
CanadaFDA applicant, unverified
- Devices
- 1
What Aerotek makes
Aerotek manufactures the Formula IV Electric Mobility Vehicle, a powered mobility aid designed for individuals with limited mobility. This device supports indoor and outdoor use, providing enhanced independence for users.
The Formula IV Electric Mobility Vehicle is classified as a Class II medical device in the US and is authorised via the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
Formula Iv Electric Mobility Vehicle Ref K954378
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Aerotek have in the registry?
The registry currently lists 1 device for Aerotek. Devices recorded under merged duplicate company entries are counted once.
Which registries list Aerotek's devices?
Among its 1 most recently registered device, Aerotek has devices listed in FDA 510(k) (1 device).
What risk classes do Aerotek's devices fall under?
Among its 1 most recently registered device, the classes recorded for Aerotek's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Aerotek in the registry?
The most recently registered devices listed for Aerotek include FORMULA IV ELECTRIC MOBILITY VEHICLE.