# K111404: Huibao Body Fat Scale

- Pathway: 510(k) (Traditional)
- Applicant: Zhongshan Huibao Weighing Apparatus Co., Ltd.
- Decided: Oct 7, 2011 after 141 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 Huibao BE-i 36 Body Fat Scale measures body weight and impedance for the person standing on the four foot electrodes, and then estimates and displays the information of body weight, total body fat percentage, total body water percentage, bone mass, and daily calorie intake(DCI) using Foot-to-Foot BIA(bioelectrical impedance analysis) method. BF-1 36 is intended for the healthy person whose age is between 10 and 80 years old

Source page: https://510kreport.com/device/K111404
Methodology: https://510kreport.com/methodology