# K082254: Modification to Bodystat 1500MDD Body Composition Monitoring Unit

- Pathway: 510(k) (Traditional)
- Applicant: Bodystat, Ltd.
- Decided: Feb 7, 2011 after 913 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 K994242 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994242: Bodystat 1500MDD Body Composition Monitoring Unit, Bodystat, Ltd. (2000) Summary page 1.
- K002835: Bodystat, Bodystat, Ltd. (2001) Summary page 1.

## Indications for use
For the purposes of performing a non-invasive BIA measurement on normal healthy human adults and children to determine their Body Composition status. The measurements include Body Mass Index (BMI), waist/hip ratio, tissue impedance at 5kHz and at 50kHz. These measurements are used to calculate the estimated levels of body fat, body lean and dry lean, total body water, and metabolic rates. Bodystat BODY MANAGER and WELLNESS SOFTWARE PROGRAMS are automatically included with this device. The Body Manager Program is designed for when a client returns to be tested in order to track their changes in body composition over a period of time. The Weliness Program is designed for first time assessments on subjects. The program's graphical presentations provide information on each of the specific measurements in an educational format.

Source page: https://510kreport.com/device/K082254
Methodology: https://510kreport.com/methodology