LifeCel Battery Pack, Model 5L500
FDA 510(k)Class III (US FDA 510(k))
Identifiers
- 510(k) Number
- K072596 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 LifeCel Battery Pack, Model 5L500, is a replacement battery pack designed for use with automated external defibrillators (non-wearable). It provides the necessary power supply for defibrillation devices, enabling them to deliver therapeutic electrical shocks during cardiac emergencies.
This battery pack is intended for single-use in a pre-hospital or clinical setting, where it is installed into compatible defibrillator units such as the Medtronic LifePak 500. It is classified as a Class III device under FDA regulations (870.5310) and has received a 510(k) clearance for cardiovascular use. Installation and evaluation should be performed by qualified personnel only.
Frequently asked questions
What is the primary purpose of the LifeCel Battery Pack, Model 5L500, and which defibrillator devices is it compatible with?
The LifeCel Battery Pack, Model 5L500, is designed exclusively as a replacement power supply for automated external defibrillators (non-wearable). It provides the electrical energy required to deliver therapeutic shocks during cardiac emergencies. This battery pack is specifically intended for installation in Medtronic LifePak 500 defibrillators and similar compatible units. It is not a standalone defibrillator but a critical component to extend or restore functionality to existing devices.
Is the LifeCel Battery Pack, Model 5L500, intended for single-use or reusable applications, and why?
The LifeCel Battery Pack, Model 5L500, is intended for single-use only. This is explicitly stated in the device description, as it is designed for installation in pre-hospital or clinical settings where it powers defibrillation devices during emergencies. Single-use ensures reliability, traceability, and compliance with medical device safety protocols, particularly for critical cardiovascular applications where performance consistency is paramount.
How is the LifeCel Battery Pack, Model 5L500, regulated, and what does this mean for purchasers?
The LifeCel Battery Pack, Model 5L500, is classified as a Class III device under FDA regulations (870.5310) and has received 510(k) clearance for cardiovascular use. This classification indicates it is a high-risk medical device subject to stringent review by the FDA’s Cardiovascular (CV) Advisory Committee. For purchasers, this means the device has undergone rigorous evaluation for safety and effectiveness, ensuring it meets FDA standards for use in life-saving defibrillation applications. The clearance also implies compliance with manufacturing, labeling, and performance requirements.
Are there multiple sizes or models of the LifeCel Battery Pack, and if so, how do I determine the correct one for my defibrillator?
The provided data specifies only one model of the LifeCel Battery Pack: the 5L500. This model is designed specifically for compatibility with the Medtronic LifePak 500 defibrillator and its variants. To ensure correct selection, purchasers or clinicians should verify the exact model of their defibrillator and confirm compatibility with the manufacturer (Amco International). Since this is a replacement part, it is critical to match the model number (5L500) to avoid functionality issues or safety risks.
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: Life+Cel or Lifecel Battery Pack, Model 5l500, Life+Cel or Lifecel Battery Pack, Model 5l500, Amco & Design Life+cel OR Lifecel Battery - allmed.wiki, LIFE+CEL BATTERY (K071164) — FDA 510 (k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K072596 | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Amco International Manufacturing & Design, Inc.
Sources (1)
- FDA 510(k) K072596 24 fields · synced Sep 18, 2026