FDA 510(k) Cleared Language Standards for Public Sector Communications

The ActiPatch bioelectric device used by the PAINKILLER platform is FDA cleared under the 510(k) pathway for general pain and inflammation indications. Editorial and public sector communications at Electrome consistently use the cleared language. 510(k) devices are FDA cleared, not FDA approved, and government partners reproducing PAINKILLER content should follow the same convention.

Why this matters

Consistent regulatory language protects patients, supports compliant procurement, and reinforces the credibility of bioelectric medicine in public sector reporting.