Walgen Medical Innoventions
Country not established
- Devices
- 3
What Walgen Medical Innoventions makes
Walgen Medical Innoventions manufactures the CASTALERT, a device designed for monitoring and alerting in orthopedic casting applications, as well as the CEMENT FUME EVACUATOR TANK & FILTER, which captures and filters fumes generated during bone cement procedures. The company also produces the LOWER EXTREMITY SUPPORT SYSTEM-LESS, a supportive device for lower limb immobilization or rehabilitation.
These devices fall under Class I regulation in the US, with the CASTALERT, CEMENT FUME EVACUATOR TANK & FILTER, and LOWER EXTREMITY SUPPORT SYSTEM-LESS listed via FDA 510(k) clearance. The company is based in the United States.
Catalogue
Castalert Ref K861292
Regimes: 510(k) Registry: 510(k)Cement Fume Evacuator Tank & Filter Ref K810542
Regimes: 510(k) Registry: 510(k)Lower Extremity Support System-Less Ref K810433
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Walgen Medical Innoventions have in the registry?
The registry currently lists 3 devices for Walgen Medical Innoventions. Devices recorded under merged duplicate company entries are counted once.
Which registries list Walgen Medical Innoventions's devices?
Among its 3 most recently registered devices, Walgen Medical Innoventions has devices listed in FDA 510(k) (3 devices).
What risk classes do Walgen Medical Innoventions's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Walgen Medical Innoventions's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Walgen Medical Innoventions in the registry?
The most recently registered devices listed for Walgen Medical Innoventions include CASTALERT, CEMENT FUME EVACUATOR TANK & FILTER and LOWER EXTREMITY SUPPORT SYSTEM-LESS.