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Batter Pack, Replacement For Physio Control Lifepak 500

FDA 510(k)

Class III (US FDA 510(k))

510(k) K141795

by R & D Batteries, Inc.

Identifiers

510(k) Number
K141795 FDA 510(k)
FDA Product Code
MKJ FDA 510(k)

Classification

Device Class
Class III FDA 510(k)
Legislation / Framework
21 CFR Part 870.5310 FDA 510(k)
Regulation Number
870.5310 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is a replacement battery pack designed for use with the Physio-Control LifePak 500 Automated External Defibrillator (Non-Wearable). It provides the necessary power supply to operate the defibrillator’s shock delivery, monitoring, and pacing functions, ensuring reliable performance during cardiac emergencies.

The battery pack is intended for single-use replacement within the LifePak 500 system and is supplied as a standalone component. It is classified as a Class III medical device under FDA regulations (870.5310) and requires compliance with FDA 510(k) clearance (K141795). No sterility or MRI safety considerations apply, as it is a non-invasive, non-implantable component. Storage should follow manufacturer guidelines to maintain functionality.

Frequently asked questions

What is the primary purpose of this battery pack, and how does it integrate with the Physio-Control LifePak 500 defibrillator?

This battery pack is designed as a single-use replacement for the Physio-Control LifePak 500 Automated External Defibrillator (Non-Wearable). It provides the necessary power supply to ensure the defibrillator’s core functions—shock delivery, cardiac monitoring, and pacing—operate reliably during emergencies. It is a standalone component meant to be swapped into the LifePak 500 system when the original battery depletes or requires replacement.

Is this battery pack reusable, or is it intended for one-time use only?

The battery pack is explicitly intended for single-use replacement within the LifePak 500 system. It is not designed for reuse, and the manufacturer recommends replacing it as needed to maintain the defibrillator’s functionality during cardiac emergencies.

How should this battery pack be stored to ensure it remains functional when needed?

While the device data does not specify exact storage conditions, it advises following manufacturer guidelines to preserve functionality. Typically, battery packs like this should be stored in a cool, dry place, away from direct sunlight or extreme temperatures, to prevent degradation. Always refer to the accompanying documentation for precise storage instructions.

What regulatory pathway was followed for this device’s approval, and what class does it fall under?

This battery pack is classified as a Class III medical device under FDA regulations (870.5310) and was cleared through the 510(k) pathway (K141795). The submission was reviewed by the FDA’s Cardiovascular (CV) Advisory Committee and determined to be substantially equivalent to a predicate device. No sterility or MRI safety considerations apply, as it is a non-invasive, non-implantable component.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
R & D Batteries, Inc.

Sources (1)

  • FDA 510(k) K141795 24 fields · synced Sep 18, 2026