Answer
Oct 17, 2025 - 07:52 AM
Yes, this battery is FDA cleared under filing 510(k) K120350. FDA clearance under 510(k) demonstrates that the battery meets regulatory standards for safety and effectiveness, which is critical for medical devices.
Has this battery received FDA clearance? Cardiac Science Powerheart G5 Battery AED Recelled Lithium
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Open Oct 17, 2025 - 07:52 AM
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Cardiac Science Powerheart G5 Battery AED Recelled Lithium
This re-celled Cardiac Science Powerheart G5 battery pack utilizes OEM components including lithium cells that match those used by the OEM. By using the same cells as those used by the OEM the re-celled packs provide the same performance and life as that of the original Powerheart G5 battery. The FD...
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