Matrix Battery Charger/Defibrillator Tester

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

Full name

Matrx Battery Charger/Defibrillator Tester

510(k) Number

K895525 ↗

FDA Product Code

DRL

Device Class

Class II

Regulation

21 CFR Part 870.5325

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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• Mitraflex(Tm) Wound Dressing

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  FDA 510(k) K873277 Active Cleared 17 Sep 1987

• Nitronox(R), First Response Nitronox(Tm)

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• Matrx Hope(R) 5 Resuscitator

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• Matrx, Pyramid Triangle Bandage

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  FDA 510(k) K912661 Active Cleared 21 Aug 1991

• Centurion(Tm) Mixer

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  FDA 510(k) K884879 Active Cleared 9 Feb 1989

See all devices from Matrix Medica, Inc. →

• What is the primary purpose of the MATRX Battery Charger/Defibrillator Tester in clinical settings?

  The MATRX Battery Charger/Defibrillator Tester is designed specifically to measure the energy output of a defibrillator when it delivers a shock to a standard resistive load. This allows clinicians and technicians to verify the accuracy and functionality of the defibrillator’s calibration, ensuring it performs reliably in life-saving situations. It’s particularly useful in pre-hospital, emergency room, or clinical environments where defibrillator maintenance is critical.

• Is the MATRX Battery Charger/Defibrillator Tester reusable or single-use, and what does that mean for maintenance?

  The MATRX Battery Charger/Defibrillator Tester is a reusable Class II medical device, meaning it is built to withstand repeated use and testing cycles. This design reduces waste and costs over time, as it can be cleaned and reused across multiple defibrillator maintenance checks. However, proper cleaning and maintenance protocols must be followed to ensure consistent performance and prevent cross-contamination between uses.

• How does the device connect to a defibrillator, and what kind of settings is it intended for?

  The MATRX Battery Charger/Defibrillator Tester connects directly to the output terminals of the defibrillator being tested. It is intended for use in environments where defibrillators are regularly maintained, such as ambulances, emergency rooms, or clinical settings with cardiac arrest protocols. The tester simulates the resistive load a defibrillator would encounter during use, allowing for precise measurement of energy output to confirm proper functionality.

• Are there any special storage requirements for the MATRX Battery Charger/Defibrillator Tester?

  According to the available regulatory filings, there are no specific storage requirements mentioned for the MATRX Battery Charger/Defibrillator Tester. However, since it is a reusable device, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures to preserve its functionality and ensure longevity. Standard medical device storage practices, such as keeping it in its original packaging or a designated storage area, are recommended.

• What regulatory pathway was followed for FDA clearance of this device, and what does that imply about its safety and equivalence?

  The MATRX Battery Charger/Defibrillator Tester received FDA clearance through a Traditional 510(k) pathway, classified as Substantially Equivalent (SESE) under the Cardiovascular Device Advisory Committee (CV). This means the device was determined to be at least as safe and effective as a legally marketed predicate device already on the market. The clearance number is K895525, and it falls under Product Code DRL, which categorizes defibrillator testers. This pathway ensures the device meets FDA standards for safety and performance.