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Mobile Battery Service Station (MBSS)

by Ad Elektronik GmbH

510(k) K030898

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 NumberK030898 Date27 Aug 2003ClearedStatusActive

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  • Withdrawn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
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.

The Mobile Battery Service Station (MBSS) is an Automated External Defibrillator (Non-Wearable) designed for recharging and servicing defibrillator batteries. It provides a portable solution for maintaining battery life and functionality in defibrillator units, ensuring readiness for emergency cardiovascular use.

The MBSS is supplied as a reusable device and is intended for use in clinical and pre-hospital settings. It is not sterile and requires proper storage to maintain operational integrity. The device holds an FDA 510(k) clearance under K-number K030898, classified as a Class III medical device, and is regulated under regulation number 870.5310. No MRI safety information is specified.

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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.

  • What is the primary purpose of the Mobile Battery Service Station (MBSS) and where is it typically used?

    The Mobile Battery Service Station (MBSS) is designed specifically to recharge and maintain defibrillator batteries, ensuring they remain functional and ready for emergency use. It is intended for use in clinical settings and pre-hospital environments, such as ambulances, emergency rooms, or public access defibrillation programs, where quick access to operational defibrillators is critical.

  • Is the MBSS a single-use or reusable device, and what does this mean for maintenance?

    The MBSS is a reusable device, meaning it is built to be used repeatedly for recharging and servicing defibrillator batteries. Since it is not single-use, proper maintenance and storage are essential to preserve its operational integrity and ensure reliable performance over time.

  • How is the MBSS supplied, and does it require any special handling or storage conditions?

    The MBSS is supplied as a reusable, non-sterile device. While it does not require sterile handling, it must be stored properly to maintain its functionality and prevent damage. This includes keeping it in a clean, dry environment and following manufacturer guidelines to avoid exposure to extreme temperatures or physical stress.

  • What regulatory pathway does the MBSS follow, and how does this affect its use?

    The MBSS holds an FDA 510(k) clearance under K-number K030898, classified as a Class III medical device, and is regulated under regulation number 870.5310. This means it has undergone a premarket review to demonstrate substantial equivalence to a legally marketed predicate device, ensuring it meets safety and effectiveness standards for use in recharging defibrillator batteries in emergency settings.