# K112951: Body Analysis Scale

- Pathway: 510(k) (Special)
- Applicant: Shenzhen Healthcare Electronic Technology Co., Ltd.
- Decided: Nov 1, 2011 after 28 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Body analysis scale, Model BF 66 is indicated to measure body weight, estimate body fat, body water percentage, body muscle mass, bones mass, visceral fat rating and daily calorie intake (DCI) using BIA (bioelectrical impedance analysis). This product is for use by generally healthy adults who are not ill, feverishW have a chronic or acute disease, or a condition that aflects the level of hydration such as pregnancy.

Source page: https://510kreport.com/device/K112951
Methodology: https://510kreport.com/methodology