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Amco Replacement Battery For Powerheart Aed, Non-Rechargeable, Model 2l561 +1 m…

FDA 510(k)

Class III (US FDA 510(k))

510(k) K082861

by Amco International Manufacturing & Design, Inc.

Identifiers

510(k) Number
K082861 FDA 510(k)
FDA Product Code
MKJ FDA 510(k)
Models / Variants
Amco Replacement Battery For Powerheart Aed, Non-Rechargeable, Model 2l561 FDA 510(k)
G3, Non-Rechargable, Model 7l561 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)

This device is a non-rechargeable replacement battery for automated external defibrillators (non-wearable), designed to provide power to Powerheart AED systems. It is classified under the nomenclature for defibrillator accessories and serves as a consumable component to maintain operational readiness of the defibrillator unit.

The battery is supplied as a standalone unit for installation in compatible Powerheart AED models (2L561 and 7L561) and is intended for single-use replacement. It is not sterilized for reuse and must be handled in accordance with manufacturer guidelines to ensure proper functionality. The device holds an FDA 510(k) clearance under the traditional review pathway and is categorized as a Class III medical device under regulation 870.5310.

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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Amco International Manufacturing & Design, Inc.

Sources (1)

  • FDA 510(k) K082861 24 fields · synced Sep 18, 2026