Renovia Inc – Leva System
Renovia Inc. is a US-based company that is leading the way in treatment and prevention of pelvic floor disorders. Their mission is to pursue scalable and cost-effective care for pelvic floor disorders.
Service Provided by Sparton:
The design center team from Sparton was engaged by Renovia to help design a home healthcare device (compliant to 60601-1-11) to give users feedback via smartphone as they perform pelvic floor exercises. The Sparton team provided full system design including electronics, software, mechanical, industrial design, and rapid prototyping from feasibility to production as well as regulatory submissions.
Full system design
- App interface that can be used with an iOS and Android device
- Wireless Bluetooth communication between device and smartphone
- Electronics embedded in USP class VI silicone
- Secure, HIPAA compliant web database
- Position and scoring algorithm
- FDA medical device requiring regulatory approval
- Expertise in compact electronics and app integration
- Proven experience in developing compact electronics-based systems for home health usage
Sparton’s knowledge and expertise in compact electronics and app integration proved to be a winning combination for Renovia Inc. Additionally, Sparton’s capabilities all the way through to full scale manufacturing was an attractive fit for Renovia Inc to continue with one organization that can support them into full commercialization. This device has obtained 510k clearance in 2014.