# K083838: Scaleman Body Fat Scales, Model: FS-148BW1 Series

- Pathway: 510(k) (Traditional)
- Applicant: Fook Tin Technologies Limited
- Decided: May 12, 2009 after 140 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.
6 later devices descend from it; 1 cites it directly.
0 of 10 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.

## Most influential descendants
- K102191: Transtek Glass Body Analyzer; Transtek Glass Body Analyzer; Transtek Glass Body Analyzer;Transtek Glass Body Analyzer (2011), 5 descendants of its own
- K112932: Transtek (2011), 2 descendants of its own
- K123781: Transtek Glass Body Fat Analyzer (2013), 1 descendant of its own
- K121971: Withings, Smart Body Scale (2012), 1 descendant of its own
- K133872: Aria Wifi Smart Scale (2014), 0 descendants of its own

## Indications for use
Family Model List 1A A series of body composition analyzers that measure body weight and impedance and estimate percentage of body fat and body water, using BIA (bioelectrical impedance analysis). They are intended for use by healthy children 10-17 years old and healthy adults with active, moderately active, to inactive lifestyles for body composition assessment in the home environment. Family Model List lB A series of body composition analyzers that measure body weight and impedance and estimate percentage of body fat and body water, bone mass and muscle mass using BIA (bioelectrical impedance analysis). They are intended for use by healthy children 10-17 years old and healthy adults with active, moderately active, to inactive lifestyles for body composition assessment in the home environment.

Source page: https://510kreport.com/device/K083838
Methodology: https://510kreport.com/methodology