Cycling and Health Tech. Industry R&D Center
TaiwanFDA applicant, unverified
- Devices
- 5
What Cycling and Health Tech. Industry R&D Center makes
The company manufactures cycling ergometers, including the BEWELL Model SC 20 for indoor training, and smart health monitoring devices like the SMARTECH Model HOLI I for physiological data tracking. It also produces manual and motorized wheelchair models, such as the Wheelchair Model 8500-II and LANDLEX Models S300X and S400X, designed for mobility assistance.
These products are regulated under FDA 510(k) clearance, with devices classified as Class I and Class II. The company’s devices are listed in the FDA’s 510(k) registry, and the manufacturer is based in the United States.
Catalogue
Bewell, Model Sc 20 Ref K043326
Regimes: 510(k) Registry: 510(k)Landlex, Model S300X Ref K050792
Regimes: 510(k) Registry: 510(k)Wheelchair, Model 8500-Ii Ref K043332
Regimes: 510(k) Registry: 510(k)Landlex Model S400X Ref K050793
Regimes: 510(k) Registry: 510(k)Smartech, Model Holi I Ref K050507
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Cycling and Health Tech. Industry R&D Center have in the registry?
The registry currently lists 5 devices for Cycling and Health Tech. Industry R&D Center. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cycling and Health Tech. Industry R&D Center's devices?
Among its 5 most recently registered devices, Cycling and Health Tech. Industry R&D Center has devices listed in FDA 510(k) (5 devices).
What risk classes do Cycling and Health Tech. Industry R&D Center's devices fall under?
Among its 5 most recently registered devices, the classes recorded for Cycling and Health Tech. Industry R&D Center's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Cycling and Health Tech. Industry R&D Center in the registry?
The most recently registered devices listed for Cycling and Health Tech. Industry R&D Center include BEWELL, MODEL SC 20, LANDLEX, MODEL S300X, WHEELCHAIR, MODEL 8500-II and LANDLEX MODEL S400X.