# K123228: Inbody 770, Inbody 570, Inbody S10, Inbody H20/Inbody H20(B)

- Pathway: 510(k) (Traditional)
- Applicant: Biospace Corporation Limited
- Decided: Mar 8, 2013 after 144 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: 7 generations back to K830292 (1983). 15 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110689: Inbody, Biospace Corporation Limited (2011) Summary page 1.

## Most influential descendants
- K141483: Biospace Body Composition Analyzer (2014), 0 descendants of its own
- K130777: Inbody (2013), 0 descendants of its own

## Indications for use
For use only in healthy subjects for Measurement of: Estimated: Skeletal Muscle Mass, Extra-Cellular Water (ECW), Intra-Cellular Water (ICW), Total Body Water (TBW), ECW/TBW, Body Fat Percentage of Body Fat (PBF), BodyLean + Dry Lean, Metabolic Rates(Basal Metabolic Rates), Segmental Lean Mass, Segmental Fat Mass, % Segmental Body Fat, Energy Expenditure of Activity, Visceral Fat Area (VFA),.Visceral Fat Level, Segmental Body Water, Body Shape Graph Actual: Weight (except for Model InBodyS 10, which requires the manual entry of weight], Body Mass Index (BMI) and Impedance Values, Height [except for Model InBody S1 and InBody H2OIInBody 1120(l1), which requires the manual entry of Height], Resistance Values [only for InBody77O, Inflody S 10], Reactance Values (for InBody77O, InBody 510], Phase Angle [for InBody77O, InBody S10]. The InBody R120 and the InBody R20@ are identical except that the @E model has Bluetooth capability for data transfer.

Source page: https://510kreport.com/device/K123228
Methodology: https://510kreport.com/methodology