Renovia Inc – Leva System

Renovia Inc. is a US-based company that is leading the way in treatment and prevention of pelvic dysfunction. Their mission is to end the epidemic of pelvic dysfunction

Service Provided by Sparton:

The design center team from Sparton was engaged by Renovia Inc to design a home healthcare device (compliant to 60601-1-11) to map out the female anatomy giving users feedback of their pelvic floor position as kegels are performed. 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 iPhone or iPod Touch
    • Wireless Bluetooth communication between device and Apple products
    • Electronics embedded in USP class VI silicone
    • Secure, HIPAA compliant web database
    • Position and scoring algorithm

 

Key Challenges:

  • 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

End Result

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 recently obtained 510k clearance.

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