# K071164: Life+Cel Battery

- Pathway: 510(k) (Traditional)
- Applicant: Amco International Manufacturing & Design, Inc.
- Decided: Dec 7, 2007 after 225 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K844187 (1985). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032051: Battery Pack, Rechargeable, Models MLA0051, MLA90479, MNC5169L/P, MNC1000EKG, MNC14649P, Access Battery, Inc. (2004) Summary page 6.
- K940842: Unipower Rechargeable Battery Pack, Unipower Corp. (1994) Summary page 6.
- K935111: Unipowerr Rechargeable Battery Pack, Unipower Corp. (1994) Summary page 6.
- K951281: R&D Batteris, Inc. Part Number 5024, 5027, 5033 and 5035, R & D Batteries, Inc. (1995) Summary page 6.
- K945869: R&D Part Nos. 5443, 5322, 5448, 5492, R & D Batteries, Inc. (1995) Summary page 7.
- (no number) OEM, GE Marquette - Patient Monitor Dash 3000/4000: named in the summary without a submission number
- (no number) OEM, Physio Control / Medtronic's - Monitor/Defibrillator (FastPak) LP5: named in the summary without a submission number
- (no number) OEM, Physio Control - Monitor/Defibrillator (Non-FastPak) LP5 / LP10: named in the summary without a submission number
- (no number) OEM, Physio Control / Medtronic's - Monitor/Defibrillator LP12 (NiCad): named in the summary without a submission number
- (no number) OEM, Health Dyne / Vickers Respironics - Smart Monitor 900 Series: named in the summary without a submission number
- (no number) OEM, CAS Medical - NIBP Monitor 740: named in the summary without a submission number
- (no number) OEM, Physio Control / Medtronic's - Monitor/Defibrillator LP12 (SLA): named in the summary without a submission number

## Cited in the summary but kept off the family tree
- K920964: Alpha Source / Access Battery. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 6.

## Indications for use
To power the functions of various devices for which batteries or battery packs are configured. Since rechargeable batteries and battery packs are "device specific", and are designed to operate and fit into the equipment for which they were manufactured, only qualified personnel should evaluate, test, charge, or install these devices. This battery is shipped only to customers who request a replacement battery for a particular device or to replace a competitor's replacement battery. Biomedical equipment service professionals, EMT's, etc. therefore know that the intended use is as a replacement battery. Only replacement battery 2L226 in this submission (Patient Monitor) is provided Over-the-Counter (OTC). All other replacement batteries, specifically; 5L375, 6L577, 7L991, 9L977, 9L990, and 9L998 in this submission (Defib/AED's) are provided by prescription only.

Source page: https://510kreport.com/device/K071164
Methodology: https://510kreport.com/methodology