# K052522: Stayhealthy Body Composition Analyzer, Models BC1 and BC2

- Pathway: 510(k) (Traditional)
- Applicant: Stayhealthy, Inc.
- Decided: Dec 13, 2005 after 90 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 K011652 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011652: Body Fat Analyzer, Model HBF-306, Omron Healthcare, Inc. (2001) Summary page 2.

## Indications for use
The Stayhealthy BC I and the Stayhealthy/Fitness Expert BC2 devices are used solely to estimate the body fat and lean muscle components of the body using bioelectrical impedance technology. The Stayhealthy Calorie tracker (CT1) and the Stayhealthy/Fitness Expert Calorie Tracker (CT2) are companion devices and are used solely to determine the calories used by a client when worn for a given period of time. The BC t and BC2 can output, via computer driven software the percent body fat of a person. The lean body mass can also be displayed. The devices are intended for use by both men and women who are 18 and older. The CT I and the CT2 the companion devices can output, via computer driven software the number calories used by a person. The calories used can also be displayed. The BC1, BC2, CT1 and CT2 are not intended to be used to diagnose any known disease.

Source page: https://510kreport.com/device/K052522
Methodology: https://510kreport.com/methodology