# K012229: Scale-Tronix 48, 2001, 2009,2700,3003,4004, 4800, 5005,5700,6005,6500,6700,6006C & 20009, Model N661WC

- Pathway: 510(k) (Traditional)
- Applicant: National Custom Ent., Inc.
- Decided: Sep 10, 2001 after 56 days
- Product code: FMT (Warmer, Infant Radiant)
- Device class: 2
- Regulation: 21 CFR 880.5130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Replacement battery pack for. SCALE-TRONIX MODEL 48, 2001, 2009, 2700, 3003, 4004, 4800, 5005, 5700, 6006, 6500, 6700, 6006C & 20009 SCALES This battery will be shipped to biomedical equipment technicians and or customers who request a replacement battery for the particular device(s) listed above

Source page: https://510kreport.com/device/K012229
Methodology: https://510kreport.com/methodology