Neuromodulation Therapy Device

Project Goals

Sunrise was asked by Biowave to take an electronic pain management system from proof-of-concept to product delivery, meeting FDA and safety guidelines.

Sunrise Solution

  • Reviewed patents and design of experimental device
  • Reduced the size and cost of the prototype
  • Developed firmware and 4-button user interface
  • Designed a similar model for home-use
  • Electronics built into disposable to prohibit overuse or third party pads
  • Provided FDA 510(k) and TUV documentation

Results

  • Successful field trials
  • FDA fast track 510(k) clearance
  • TUV Certification (class II medical device)
  • Client received additional funding

see the BiowavePRO Neuromodulation Pain Therapy used on sidelines at NFL game