Energy type, character, or source

A change in energy type is one of the design changes FDA's 510(k) change guidance walks through, because it can affect safety or effectiveness. The manufacturer assesses the change against the guidance and documents the decision.

The type of power input to or output from the device. Examples of a change in energy type or character would be a change from AC to battery power (input) or a change from ionizing radiation to ultrasound to measure a property of the body (output).

FDA guidance: Deciding When to Submit a 510(k) for a Change to an Existing Device (October 2017), Appendix C, Significant Terminology