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Powrpak Replacement Batteries for Phisio-Control Lifepak 5/10

by National Custom Ent., Inc.

510(k) K934067

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK934067 Date7 Oct 1993ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DRK
Device Class
Class III
Regulation
21 CFR Part 870.5300
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a replacement battery pack for high-energy defibrillators, classified under the nomenclature for defibrillator, high energy (including paddles). It provides the necessary electrical power to operate the Physio-Control LifePak 5 and LifePak 10 defibrillators, enabling critical cardiac resuscitation procedures in emergency and clinical settings.

The PowrPak batteries are designed for single-use replacement in defibrillator systems and are regulated under 21 CFR 870.5300 as a Class III device. They are supplied as standalone units, intended for use with compatible defibrillator models only, and require no sterilization. Authorized by FDA 510(k) clearance (K934067), these batteries are distributed under the product code DRK and must be stored in a dry, temperature-controlled environment to maintain functionality.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • Are these replacement batteries compatible with any defibrillator, or only specific models like the Physio-Control LifePak 5 and LifePak 10?

    These PowrPak replacement batteries are exclusively designed for the Physio-Control LifePak 5 and LifePak 10 defibrillators. They are not intended for use with other models, even if they share similar functionality. Always verify compatibility with the manufacturer’s documentation before installation.

  • Do these batteries require sterilization before use, or are they ready to install out of the package?

    The PowrPak batteries are pre-packaged for single-use and do not require sterilization. They are supplied sterile and ready for immediate installation in compatible LifePak 5/10 defibrillators, ensuring no additional preparation is needed in emergency settings.

  • How should these batteries be stored to ensure they remain functional when needed?

    To maintain functionality, PowrPak batteries must be stored in a dry environment with controlled temperature. Avoid exposure to moisture, extreme heat, or cold, as these conditions can degrade performance. Check the packaging for any additional storage instructions.

  • Are these batteries reusable, or are they intended for one-time use only?

    These PowrPak batteries are designed for single-use replacement in the LifePak 5/10 systems. They are not meant to be recharged or reused, as their performance may degrade over time or repeated use. Always replace them with a new unit when needed.