# K092431: Body Composition Analyzer, Model: Ioi 353

- Pathway: 510(k) (Special)
- Applicant: Jawon Medical Co., Ltd.
- Decided: Oct 8, 2009 after 62 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: 5 generations back to K930599 (1994). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071884: Body Composition Analyzer, Models: X-Scan Plus II, Gaia 359 Plus, Plusavis 333, Xbia 500, Xbia 900, Jawon Medical Co., Ltd. (2007) Summary page 1.

## Most influential descendants
- K140045: Body Composition Analyzer (2015), 0 descendants of its own

## Indications for use
This device is intended to estimate PBF(Percentage of Body Fat), MBF(Mass of Body Fat), LBM(Lean Body Mass), TBW(Total Body Water), BMI(Body Mass Index), BMR(Basic Metabolic Rate), Segmental LBM, ICW(Intra-Cellular Water), ECW(Extra-Cellular Water), and ratio of ECW/TBW using the BIA(Bio-electrical Impedance Analysis) method. The device measures or calculates the impedance, BMI(Body Mass Index), weight, and WHR(Waist to Hip Ratio) of the user. This devices is intended for use only in healthy subjects between the age of 7-89.

Source page: https://510kreport.com/device/K092431
Methodology: https://510kreport.com/methodology