# K122976: Body Fat Scale Model SF-371

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Belter Health Measurement and Analysis TE
- Decided: Jan 4, 2013 after 100 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 Shenzhen Better Health Measurement and Analysis Technology Co., Ltd. Body Fat Scale SF-371 measures body weight, and estimates body fat, body water, body muscle mass and body bone mass using BIA (bloelectrical impedance analysis). The device is intended to be used by generally healthy people (from age 16 to age 80) who are not ill, feverish, have a chronic or acute disease, or a condition that affects the level of hydration such as pregnancy.

Source page: https://510kreport.com/device/K122976
Methodology: https://510kreport.com/methodology
