Project Goals

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

Sunrise Labs 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