unipower Rechargeable Battery Pack M5070A,510(k) Number:k935111

Experience reliable, medical-grade performance with this FDA 510(k) cleared (K935111) rechargeable replacement battery pack, designed specifically for Philips HeartStream FRx and Home/OnSite AEDs.
Engineered to meet stringent U.S. FDA safety and quality requirements, this battery pack delivers dependable power when every second counts.

Approved under FDA 510(k) K935111 as a substantially equivalent Class II medical device, this battery pack ensures compliance with U.S. medical device regulatory standards, including labeling, quality system requirements, and general controls mandated by the Food and Drug Administration. 

Featuring a 4-year shelf life from the date of manufacture and built for consistent readiness, it provides long-lasting energy to support AED reliability in public spaces, workplaces, schools, and home emergency preparedness. 

Choose a replacement battery backed by FDA documentation for safety, performance, and peace of mind.