Renovia, Inc.
United StatesFDA applicant, unverified
- Devices
- 4
What Renovia, Inc. makes
Renovia, Inc. manufactures medical devices for pelvic health, including the Leva Pelvic Health System and the LEva Pelvic Digital Health System. These products are designed to support pelvic floor training and digital health monitoring for women’s health applications.
The company’s portfolio is regulated as Class II devices under the FDA’s 510(k) clearance pathway. These devices are listed in the FDA’s 510(k) registry and are based in the United States.
Catalogue
Leva Pelvic Health System Ref K212495
Regimes: 510(k) Registry: 510(k)leva Pelvic Floor Trainer Ref K180637
Regimes: 510(k) Registry: 510(k)leva Pelvic Health System Ref K213913
Regimes: 510(k) Registry: 510(k)LEva Pelvic Digital Health System Ref K192270
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Renovia, Inc. have in the registry?
The registry currently lists 4 devices for Renovia, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Renovia, Inc.'s devices?
Among its 4 most recently registered devices, Renovia, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Renovia, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Renovia, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Renovia, Inc. in the registry?
The most recently registered devices listed for Renovia, Inc. include Leva Pelvic Health System, leva Pelvic Floor Trainer and LEva Pelvic Digital Health System.