# K073716: Life+Cel or Lifecel Battery

- Pathway: 510(k) (Traditional)
- Applicant: Amco International Manufacturing & Design, Inc.
- Decided: Apr 11, 2008 after 102 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: 1 generation back to K013425 (2002). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013425: Heartstream/Heartstart FR2 Aed Ecg Cable, Models M3860A, M3861A, M3840A, M3841A, Philips Medical Systems (2002) Summary page 2.

## Indications for use
The 6L785 Sealed Manganese Dioxide (MnO2) life+cel (or lifecel) is a replacement disposable battery pack, for use in the Philips Medical Systems FR2 Series AED, specifically OEM Part Number M3863A. This battery pack has a shelf life of 5 years from the date of manufacture.

Source page: https://510kreport.com/device/K073716
Methodology: https://510kreport.com/methodology