# K053556: Body Composition Analyzer, Models Zeus 9.9 and Venus 5.5

- Pathway: 510(k) (Traditional)
- Applicant: Jawon Medical Co., Ltd.
- Decided: Aug 31, 2006 after 254 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: 3 generations back to K930599 (1994). 4 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002835: Bodystat, Bodystat, Ltd. (2001) Summary page 1.
- K033157: Tanita Segmental Body Composition Analyzer, Model BC-418, Tanita Corp. of America (2004) Summary page 1.

## Most influential descendants
- K071884: Body Composition Analyzer, Models: X-Scan Plus II, Gaia 359 Plus, Plusavis 333, Xbia 500, Xbia 900 (2007), 2 descendants of its own
- K092431: Body Composition Analyzer, Model: Ioi 353 (2009), 1 descendant of its own
- K072325: Body Composition Analyzer, Easybody 202, 203, 205 (2007), 1 descendant of its own
- K140045: Body Composition Analyzer (2015), 0 descendants of its own

## Indications for use
The ZEUS 9.9 and VENUS 5.5 body composition analyzers are intended to estimate PBF(Percentage of Body Fat), MB3F(Mass of Body Fat), LBM(Lean Body Mass), TBW(Totnl Body Water), BMI(Body Mass Index), BMR(Basic Metabolic Rate), Segmental LBM, ICW(Intra-Cellular Water), ECW(Extra-Cellular Water), and ratio of ECWITr3W using the BIA(Bio-electrical Impedance Analysis) method. The device measures or calculates the impedance, BMI(Body Mass Index), weight, arid WHR@Vaist to Hip Ratio) of the user- These devices are Intended for use only in healthy subjects between the age of 7-89. The only difference between the ZEUS 9.9 and VENUS &-5 is head part of main unit; that is, the head part of the ZEUS 9.9 has a key pad and touch screen while the head part of the VENUS 5.5 has only a touch screenL

Source page: https://510kreport.com/device/K053556
Methodology: https://510kreport.com/methodology