# K140045: Body Composition Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Jawon Medical Co., Ltd.
- Decided: Feb 18, 2015 after 406 days
- Product code: MNW (Analyzer, Body Composition)
- Device class: 2
- Regulation: 21 CFR 870.2770
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K930599 (1994). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092431: Body Composition Analyzer, Model: Ioi 353, Jawon Medical Co., Ltd. (2009) Summary page 5.
- K072325: Body Composition Analyzer, Easybody 202, 203, 205, Jawon Medical Co., Ltd. (2007) Summary page 5.

## Indications for use
These devices calculates and estimates body composition parameters by using measured weight and impedance and entered height, age and gender. It shows body composition of Weight, Standard weight, Lean Body Mass, Total Body Water, Intra Cellular Water, Extra Cellular Water, B.M.I. (Body Mass Index), Mass of Body Fat, Percent of Body Fat, Basal Metabolic Rate, Impedance, Body Type, Target to Control, Goal setter. In case of whole body, it shows more items including Waist to Hip Ratio, Ratio of E.C.W. /T.B.W., Segmental analysis (lean body mass of arms, legs, and trunk). These devices can only estimate the body composition parameters with the exception of Weight, BMI, and impedance. These devices are only for use with generally healthy individuals of a specified age range.

Source page: https://510kreport.com/device/K140045
Methodology: https://510kreport.com/methodology