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.
- 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
- 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
Check out the Wireless EEG Headset case study