Identifiers
- 510(k) Number
- K120350 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)
The Extended Life Battery is a replacement power source designed for Automated External Defibrillators (Non-Wearable). It provides extended operational runtime compared to standard batteries, ensuring prolonged availability for emergency cardiac interventions in out-of-hospital settings. This device is intended for use in defibrillators that require reliable power delivery during resuscitation efforts.
Supplied as a single-use component, the Extended Life Battery is compatible with multiple defibrillator models as referenced by its product code (MKJ). It is not sterile and must be handled with care to avoid contamination. The device is regulated under FDA 510(k) clearance (K120350) and falls under Class III medical device classification (870.5310), adhering to cardiovascular device standards. Storage should follow manufacturer guidelines to maintain functionality.
Frequently asked questions
What types of defibrillators is the Extended Life Battery compatible with, and how do I verify compatibility with my specific model?
The Extended Life Battery is designed for use with Automated External Defibrillators (Non-Wearable) and is compatible with multiple models listed under the FDA product code MKJ. To verify compatibility with your specific defibrillator, check if its model number appears in the provided registration numbers (e.g., 3026976873, 1218058, etc.) or consult the manufacturer’s documentation for your device. Since it’s a replacement battery, it should fit defibrillators requiring extended runtime for emergency cardiac interventions.
Is the Extended Life Battery single-use or reusable, and how should it be handled to maintain performance?
The Extended Life Battery is single-use only, meaning it is intended for one-time installation in a defibrillator. While not sterile, it should be handled with care to avoid contamination, as improper handling could compromise its functionality. Follow the manufacturer’s storage guidelines to preserve its operational integrity until use.
What regulatory pathway does the Extended Life Battery follow, and what does that mean for users?
The Extended Life Battery is regulated under FDA 510(k) clearance (K120350) and classified as a Class III medical device (870.5310), adhering to cardiovascular device standards. This means it has undergone FDA review to ensure safety and effectiveness as a replacement power source for defibrillators, providing assurance of its reliability for emergency cardiac interventions.
How does the Extended Life Battery differ from standard defibrillator batteries in terms of runtime?
The Extended Life Battery is specifically designed to provide extended operational runtime compared to standard batteries, ensuring prolonged availability during resuscitation efforts in out-of-hospital settings. This extended capacity is particularly useful in scenarios where prolonged defibrillator use may be required, such as during prolonged cardiac arrest events.
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. Sources consulted: Extended Exchange | One Margin for All Markets
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K120350 | Class III | Active |
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Manufacturer
- Manufacturer
- AED Battery Exchange, LLC
Sources (1)
- FDA 510(k) K120350 24 fields · synced Sep 18, 2026