RF Puncture Generator


Project: RF Puncture Generator

Client Need:

  • Improve appearance and functionality of the predicate product including increased accuracy and output.
  • A partner that provides world class customer support for design, manufacture and service instead of a supplier that does not.

How RBC Added Value:

The best value we provide for this client is the comfort knowing they have a proactive, trusted partner for their products. We completed this product design – from start to verified system – in 12 months and have been providing responsive, reliable manufacturing and support services ever since.

Specifically for this radio frequency generator, which delivers high-accuracy, controlled tissue puncture using radiofrequency energy, RBC:

  • Increased output voltage: From 200V to 400V to allow greater treatment efficacy
  • Increased precision: Shorter, higher-energy bursts facilitating pinpoint energy delivery
  • Protected against obsolescence: We sourced a more appropriate bill of materials and updated the DHR accordingly
RBC’s speed of innovation, flexibility and dependability creates long term partnerships with our clients.
Customized Manufacturing Solutions

Our flexibility in development and manufacturing provides client focused solutions that meet their unique needs.

This client created the market for controlled tissue puncturing and required one RF Puncture Generator unit at a time. While many manufactures would be unwilling to support low volumes, we collaborated with the client to setup a responsive manufacturing scenario to scale production to the market demand.

Our willingness to solve this unique customer need has resulted in a multi-project partnership lasting over 10 years!

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510(K), PMA, AND CE MARK SUBMISSIONS

Depending on your needs, RBC Medical Innovations can produce all or part of the design documentation required for a FDA 510(k) submission, pre-market approval, or a CE Mark technical file.