# K062652: Innerscan Body Composition Monitor, Innerscan Segmental Body Composition Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Tanita Corporation of America
- Decided: Dec 28, 2006 after 112 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). 4 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 12 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.
- K033157: Tanita Segmental Body Composition Analyzer, Model BC-418, Tanita Corp. of America (2004) Summary page 1.

## Most influential descendants
- K062603: Biospace Body Composition Analyzers, Model Inbody 230 (2007), 6 descendants of its own
- K092786: Inbody, Models: 270, R20, R20B (2010), 4 descendants of its own
- K110689: Inbody (2011), 3 descendants of its own
- K123228: Inbody 770, Inbody 570, Inbody S10, Inbody H20/Inbody H20(B) (2013), 2 descendants of its own
- K141483: Biospace Body Composition Analyzer (2014), 0 descendants of its own

## Indications for use
The TANITA Ironman Innerscan Body Composition Monitor measures body weight, impedance and estimates total and segmental body fat percentage, body water, total and segmental muscle mass, physique rating, bone mass, visceral fat rating with healthy range, basal metabolic rate(BMR), daily caloric intake(DCI) and metabolic age using BIA (Bioelectrical Impedance Analysis). The device is intended to be used by generally healthy children 7-17 years old and generally healthy adults with active, moderately active, to inactive lifestyles for body composition assessment in the home environment. Actual measurements made by the BC-558 include weight and impedance. Based upon these measured values, values are calculated for: total and segmental body fat percentage, body water, total and segmental muscle mass, physique rating, bone mass, visceral fat rating with healthy range, basal metabolic rate (BMR), daily caloric intake (DCI) and metabolic age.

Source page: https://510kreport.com/device/K062652
Methodology: https://510kreport.com/methodology