# K050395: Impedimed - Body Composition Analysis

- Pathway: 510(k) (Traditional)
- Applicant: Impedimed Pty, Ltd.
- Decided: Jul 13, 2005 after 147 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: 1 generation back to K830292 (1983). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K830292: Bioelectrical Impedance Analyzer #101, Rjl Systems, Inc. (1983) Summary page 2.
- K994242: Bodystat 1500MDD Body Composition Monitoring Unit, Bodystat, Ltd. (2000) Summary page 2.

## Most influential descendants
- K070999: BC (Body Composition Software) (2007), 1 descendant of its own
- K103026: Electro Sensor -Body Composition (2011), 0 descendants of its own

## Indications for use
A body composition analyzer and a software package that will estimate, display and store the following body composition parameters: Fat-free Mass (FFM), Fat Mass (FM), Total Body Water (TBW), Intra cellular Water (ICW), Extra cellular Water (ECW), Body Mass Index (BMI) and Basal Metabolic Rate (BMR). The device measures current, voltage and phase angle (Phi), and from these values calculates resistance (R), reactance (Xc), and impedance (Z), which are used to estimate the above body composition parameters. The device/software will also display the users height, weight, age, % ideal weight, time and date of measurement, Practitioner's name and Device serial number. This device is intended for use on healthy children (9 - 16 years old), general and obese adult subjects, only for body composition assessment in the home or clinical environment.

Source page: https://510kreport.com/device/K050395
Methodology: https://510kreport.com/methodology