# K060538: Beaverite Body Fat Scales, Models 8901, 8903, 8905, 8909, 8911, 8915, 9563 and 9568

- Pathway: 510(k) (Traditional)
- Applicant: Beaverite International Limited
- Decided: Oct 10, 2006 after 224 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). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040778: Tanita Innerscan Body Composition Monitor, Model BC-53X (Where X=0 to 9), Tanita Corp. of America (2004) Summary page 1.

## Indications for use
The Beaverite Body Fat Scales -- Models 8921, 8925, 8931, 8935 and 9576 -- measure body weight and impedance, and estimate percentages of body fat and total body water. They are intended for use by healthy adults. The Beaverite Body Fat Scales -- Models 8919, 8923, 8929, 9580, 9583, and 9588 -- measure body weight and impedance, and estimate percentages of body fat, total body water, and total muscle mass. They are intended for use by healthy adults.

Source page: https://510kreport.com/device/K060538
Methodology: https://510kreport.com/methodology
