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BATTERY PACK, RECHARGEABLE - MNC14649P

by Access Battery, Inc.

510(k) K032051

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK032051 Date9 Jan 2004ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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
MKJ
Models / Variants
P
MNC14649P
Device Class
Class III
Regulation
21 CFR Part 870.5310
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 rechargeable battery pack designed for use with automated external defibrillators (non-wearable). It provides the necessary power supply to deliver defibrillation shocks during cardiac emergencies, ensuring reliable operation in life-saving scenarios.

The battery packs are supplied as reusable components, intended for integration with defibrillator systems. They are classified as Class III devices under FDA regulations and have received a 510(k) clearance for use in cardiovascular applications. Each model (MLA0051, MLA90479, MNC5169L/P, MNC1000EKG, MNC14649P) is registered under the respective FDA registration numbers and product code MKJ.

Other devices from Access Battery, Inc.

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 battery packs designed for single-use or can they be recharged and reused with compatible defibrillators?

    These battery packs are explicitly designed as rechargeable and intended for reuse with automated external defibrillators (non-wearable). They are not single-use and are meant to be integrated into defibrillator systems for repeated use after recharging.

  • What models are available for this rechargeable battery pack, and how do I determine compatibility with my defibrillator?

    Five models are available: MLA0051, MLA90479, MNC5169L/P, MNC1000EKG, and MNC14649P. Compatibility depends on your specific defibrillator system—check your device’s manual or consult the manufacturer to confirm which model aligns with its power requirements. These packs are registered under the product code MKJ for cardiovascular applications.

  • How are these battery packs supplied, and do they come pre-installed in the defibrillator?

    These battery packs are supplied as separate, reusable components and are not pre-installed in the defibrillator. They are designed to be integrated into compatible automated external defibrillator systems as needed, allowing for modular replacement or recharging.

  • Are there any special storage requirements for these rechargeable battery packs?

    While the data does not specify exact storage conditions, rechargeable battery packs generally require protection from extreme temperatures, moisture, and physical damage. For optimal performance and longevity, store them in a cool, dry place away from direct sunlight or heat sources, following the manufacturer’s guidelines for your specific model.