# K082861: Amco Replacement Battery for Powerheart Aed, Non-Rechargeable, Model 2L561; G3, Non-Rechargable, Model 7L561

- Pathway: 510(k) (Traditional)
- Applicant: Amco International Manufacturing & Design, Inc.
- Decided: Nov 25, 2008 after 57 days
- Product code: MKJ (Automated External Defibrillators (Non-Wearable))
- Device class: 3
- Regulation: 21 CFR 870.5310
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K970741 (1997). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031987: Powerheart Aed G3, Model 9300, Cardiac Science (2003) Summary page 1.
- K040438: Powerheart Aed G3A, Cardiac Science, Inc. (2004) Summary page 1.

## Indications for use
The 2L561 Lithium Sulfur Dioxide (LiSO2) AMCO battery is a disposable replacement battery pack for use in the Cardiac Science PowerHeart® AED; specifically Cardiac Science Model / Part Number 9141-001. This battery has a shelf life of 4 years from the date of manufacture. The 7L877 Lithium Sulfur Dioxide (LiSO2) AMCO battery is a disposable replacement battery pack for use in the Cardiac Science PowerHeart® AED G3; specifically Cardiac Science Model / Part Number 9146-001. This battery has a shelf life of 4 years from the date of manufacture.

Source page: https://510kreport.com/device/K082861
Methodology: https://510kreport.com/methodology